TempSure Envi aftercare instructions

Key takeaways

The free download is a single-page TempSure Envi aftercare handout, not a consent form, screening checklist or protocol pack.

In the US, the 10, 15 and 20 mm handpieces are cleared for non-ablative treatment of mild to moderate facial wrinkles and rhytids.

Larger handpieces are cleared for tissue heating for temporary pain relief, muscle spasm and local circulation, and the massage device for cellulite appearance.

No Cynosure TempSure clearance names dry eye or meibomian gland dysfunction, so periocular treatment for those conditions is off-label.

Record the handpiece, temperature set point, treated area and any off-label decision for every session, then send the aftercare sheet from the same record.

TempSure Envi sells easily, and it over-promises just as easily. In fact, search the device and you will find pages claiming an FDA clearance for dry eye and meibomian gland treatment. Yet no Cynosure filing says that.

That distance between marketing and paperwork creates risk for the practice. For example, a consent form that calls periocular dry eye treatment FDA-cleared claims something no filing supports. Similarly, a session note without a handpiece size and set point cannot be rebuilt a year later.

In fact, three uses are cleared in the US, and dry eye is not one of them. The section below sets out the cleared indications in the FDA’s own terms, so you can check your consent form and website against them.

The aftercare sheet above is the patient-facing half of that record. In other words, it is post-treatment guidance only, with no consent form, no screening checklist and no protocol pack inside it. Instead, you write those three yourself, and this page sets out what each should carry.

What is TempSure Envi?

TempSure Envi is a radiofrequency platform for non-invasive skin tightening and wrinkle smoothing. Cynosure, based in Westford, Massachusetts, specifically makes it as part of the wider TempSure platform.

The device heats dermal and subdermal tissue rather than cutting or injecting. In FDA terms it sits under 21 CFR 878.4400, as an electrosurgical cutting and coagulation device, product code GEI. Additionally, the massage applicator adds a second product code, PBX.

First, which handpiece you fit decides which indication you are working under. That distinction runs through the whole clearance, so it belongs in your notes as well as your protocol.

• 10, 15 and 20 mm handpieces: non-ablative treatment of mild to moderate facial wrinkles and rhytids
• 18, 25, 30 and 60 mm handpieces and FlexSure applicators: tissue heating for temporary pain relief, muscle spasm and local circulation
• Massage device: temporary reduction in the appearance of cellulite
• Generator surgical modes: coagulation, cutting, blended cutting and coagulation, fulguration and bipolar work

What the FDA clearance covers in the US

The clearance covers facial wrinkles, tissue heating and cellulite appearance, and dry eye is not on the list. Specifically, six Cynosure filings cover the TempSure family: K171262, K182365, K190678, K200241, K212891 and K223292. The wording below comes from K182365, cleared on October 24, 2018.

The indications for use on that clearance cover four things:

• The 10 mm, 15 mm and 20 mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids
• The 25 mm and 30 mm handpieces provide heating to elevate tissue temperature for selected medical conditions. In the FDA wording those are temporary relief of pain and muscle spasms and an increase in local circulation
• The massage device is intended to provide a temporary reduction in the appearance of cellulite
• The generator carries surgical modes for coagulation and hemostasis, cutting, blended cutting and coagulation, fulguration and bipolar work

A later filing, K200241, added the 18 mm and 60 mm handpieces and the FlexSure applicators to the heating indication. However, the three aesthetic indications themselves did not change. The mapping below sets out the whole cleared set, handpiece by handpiece.

Read all six indications-for-use forms and neither dry eye nor meibomian gland dysfunction appears once. Indeed, Cynosure does not claim that indication in its own TempSure Envi material either.

Treating outside a cleared indication is legal for a licensed practitioner. However, describing an uncleared use as FDA-cleared is what creates risk. Therefore, keep the two apart in your marketing, your consent forms and your clinical notes.

Where dry eye and meibomian gland treatment stand

Periocular radiofrequency for dry eye and meibomian gland dysfunction is an off-label use of the general tissue-heating indication. In other words, it is not a second cleared indication, and it is not a dual indication.

Eye-care practices do offer it, and the published evidence for radiofrequency in meibomian gland dysfunction is growing. For example, a 2026 randomized controlled trial in The Ocular Surface tested the approach directly. Evidence in the literature is still not a clearance.

So if you offer it, say so plainly. Your consent form should state that the use is off-label, name the alternatives, and record that the patient understood both. Likewise, your website and your intake material should not call it FDA-cleared.

How the device works

The handpiece delivers controlled radiofrequency energy to heat tissue without burning the surface. Meanwhile, temperature monitoring runs in real time, and the clinician adjusts contact pressure and movement speed to keep the heat effective without overheating the skin.

That heat activates fibroblasts in the dermis. Collagen contracts right away, then remodels over the following 8 to 12 weeks. Consequently, patients see progressive tightening, better texture and softer fine lines as new collagen builds up.

Treatment areas and how to document them

• Face and forehead: horizontal forehead lines and general skin tightening
• Periorbital area: crow’s feet, under-eye laxity and fine lines; periocular dry eye work is off-label and recorded as such
• Cheeks and midface: skin laxity and sagging contours
• Jawline and lower face: jowl softening and chin tightening
• Neck and decolletage: texture improvement and tightening of loose skin

Settings and session count vary with tissue laxity, age, skin type and patient goals. Therefore, your own consent form should name the areas you treat, and your notes should carry the clinician’s assessment of whether the patient is a good fit for each one.

Who makes a good candidate, and who to screen out

Thorough intake screening protects the patient and reduces your liability. Specifically, a consultation form template should capture absolute contraindications and relative risk factors in the same pass.

Absolute contraindications

• Active implanted medical devices such as pacemakers, defibrillators and neurostimulators
• Metallic implants in the treatment area, including surgical hardware and non-removable jewelry
• Pregnancy, since radiofrequency safety in pregnancy is not established
• Active skin infection or an open wound in the treatment area
• A history of keloid or hypertrophic scar formation

Relative contraindications and risk factors

• Recent sun exposure or an active suntan
• Fitzpatrick skin types V to VI, which carry higher burn risk and need a settings adjustment
• Active inflammatory skin conditions such as acne, eczema and psoriasis
• A recent chemical peel, laser treatment or aggressive skincare course, pending healing
• Medication that makes skin more sensitive to light, or slows wound healing
• Unrealistic expectations or untreated mental health concerns

First, record every screening answer in an aesthetic intake questionnaire format. That record is your proof that the assessment happened before the handpiece came out.

Treatment protocol and the settings to record

Cynosure clinician training sets the baseline parameters for each area. Then, your protocol document should hold those reference figures plus whatever your practice adjusts for comfort and safety.

• Session length: 30 to 45 minutes, depending on the area treated and patient tolerance
• Handpiece movement: continuous overlapping passes at steady pressure and speed for even heating
• Temperature: monitor skin response and patient comfort throughout, and log the set point you used
• Session spacing: usually 7 to 10 days apart, over a course of 3 to 6 sessions
• Maintenance: 1 to 2 sessions a year to hold results as collagen remodels naturally

Keep the protocol where the whole team can reach it. For example, storing it with your digital consent forms means every clinician works from the current version rather than a printout.

Risks, side effects and safety considerations

Informed consent needs a plain account of what can go wrong. Overall, most effects are temporary and settle on their own, and serious complications stay rare when contraindications are respected and settings are correct.

Expected post-treatment effects

• Temporary redness: usually resolves within 30 minutes to 2 hours
• Mild swelling: can persist 4 to 24 hours, especially around the eyes
• Warmth and a flushed sensation: expected during treatment and for 1 to 2 hours after
• Slight discomfort or tingling: usually mild, and cooling during treatment helps

Uncommon and serious risks

• Thermal burn or blistering, from inappropriate settings or patient movement
• Temporary numbness or altered sensation, which usually resolves within days
• Permanent scarring, which is extremely rare with sound technique
• Pigment change, including post-inflammatory hyperpigmentation in darker skin types
• Infection, where post-treatment instructions are not followed

Your consent form must say that results vary and are not guaranteed. Additionally, record that the patient received automated aftercare instructions and agreed to follow them.

Expected results and what to tell patients

Set the timeline early so patients do not abandon a course halfway through. Indeed, results arrive gradually, as collagen remodeling catches up with the treatment.

• First week: redness and swelling settle, and the skin may already feel slightly tighter
• Weeks 2 to 4: progressive tightening and better texture as collagen begins to remodel
• Weeks 8 to 12: peak result as collagen matures, with improvement sustained for 6 to 12 months
• Course length: most patients need 3 to 6 sessions, spaced 7 to 10 days apart

Add before-and-after photos to the conversation. Photograph at baseline and 12 weeks after the final session, in the same lighting and at the same angles, so the comparison means something.

What is inside the aftercare handout

The template is a one-page patient handout with a confirmation line at the end. It runs in the order patients need it, from the first hour after treatment through to long-term care.

• Immediately after treatment: what mild redness, warmth and tingling mean, and what not to do to the treated skin
• First 24 to 48 hours: cool compresses, no makeup or harsh cleansers, and no strenuous exercise, hot showers or saunas
• First week: gentle cleansing and moisturizing, sun avoidance, SPF 30 or higher, and no peels or retinol until cleared
• First month: gradual change in firmness and texture, further sessions where planned, and follow-up appointments
• When to contact us: severe or persistent redness, swelling or pain, signs of infection, or any unusual reaction
• Long-term care and confirmation: ongoing skincare and sun protection, plus a line for the patient to confirm they understood

That is the whole document. In fact, it is not a consent form, a screening checklist or a protocol guide, and it makes no claim about dry eye or meibomian glands. Instead, build those three around it, using the sections above.

How to use the handout in your practice

In fact, patients keep little of what they hear at the end of an appointment. Talk the sheet through in the room, then send a copy home so the guidance survives the drive back.

Add your practice phone number, email and online booking link before you send it. After all, a patient who is worried at 9pm should not have to hunt for a way to reach you.

Then log the send. In fact, a dated record that this patient received these instructions is worth as much as the instructions themselves if an adverse event is ever reviewed.

Who the handout is for

Aesthetic practices, medical spas, dermatology groups and laser providers running TempSure Envi or a similar radiofrequency device need the same post-treatment wording every time. In short, a standard handout means every patient leaves with the same guidance, whoever treated them.

Eye-care practices using periocular radiofrequency for dry eye also need aftercare wording. However, their consent form has to carry an off-label statement, which this patient handout does not.

In particular, multi-location groups get the most from it. One version-controlled document keeps every site giving the same advice, instead of five slightly different printouts.

Benefits of a standard aftercare sheet

Steady patient communication: every patient hears the same timeline, the same restrictions and the same warning signs, session after session.

Fewer needless calls: the handout separates normal reactions from the ones that need a phone call, so patients know which is which.

Smoother workflows: nobody rewrites aftercare advice between appointments, and new staff have a ready reference from their first shift.

A record of what you sent: a standard document with a confirmation line proves what the patient was told and when they acknowledged it.

Audit readiness: a standard aftercare routine shows an inspector or a state licensing board that patients were told what to expect and how to reach you.

The handout supports your consent form, and it does not replace it. Still, consent, screening and protocol records stay your practice’s own documents.

How Pabau documents TempSure Envi sessions and automates aftercare

In many practices this workflow lives in three places. For example, consent sits in a paper folder, the session details live in a calendar note, and the aftercare sheet gets printed when someone remembers. As a result, across a six-session course, that paperwork drifts apart.

Instead, practice management software like Pabau holds all three on one client record. The consent form goes out before the appointment and comes back signed and timestamped. It then stays attached to the patient rather than to a filing cabinet.

Session notes use your own template, so the handpiece, set point, treated area and any off-label decision each get a field. For instance, Pabau Scribe, our AI scribe, can draft that note from your dictation and leave you to check it.

Mark the session complete and the aftercare sheet sends itself, by email or SMS, with the send logged against the client record. As a result, nobody prints anything, and no patient leaves without instructions.

Keep TempSure Envi consent, notes and aftercare in one record

Pabau sends digital consent before the appointment and stores each session’s settings against the patient. The aftercare sheet then goes out automatically when you mark the session complete.

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Conclusion

TempSure Envi earns its place in a skin service, as long as the words around it match the filings behind it. In short, the clearance is narrower than the marketing, and that is the practical lesson here.

Three claims hold up. First, the small handpieces treat mild to moderate facial wrinkles non-ablatively. Second, the larger ones heat tissue for temporary pain relief and local circulation. Finally, the massage device reduces the appearance of cellulite temporarily.

Dry eye and meibomian gland treatment stay off-label, however well they work in your hands.

So do three things this week. Download the aftercare sheet, then strip any dry eye clearance language out of your consent form and your website. Finally, give every session note a field for handpiece size and temperature set point. Book a demo to see how Pabau keeps those records together.

Continue your research

Need a customizable consent form framework? Consultation form template provides a structured intake format for documenting patient history and candidacy assessment before any aesthetic treatment.

Want to track before-and-after results? Before and after photo management helps clinicians standardize patient photography and organize visual documentation for outcome tracking and marketing.

Looking for regulatory guidance on clinic documentation? Safer clinical notes covers best practices for writing audit-proof treatment records that protect your clinic during compliance review.

Frequently asked questions