Cynosure TempSure Envi

Monopolar RF Tightening · 300W monopolar RF, Therapeutic Logic Control

CurrentFDA status under reviewBe the first to review

What it's actually cleared for: Current clearance K223292 (Cynosure LLC, November 2022, verified) — non-ablative treatment of mild-to-moderate facial wrinkles/rhytids plus tissue heating and temporary cellulite-appearance reduction; original platform cleared 2017. "Skin tightening" on the body is off-label marketing shorthand.

Last verified: August 6, 2026 · How we verify

New: $30k–$60k|Used: $12k–$25kmarket estimate, no email required

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Bottom line

The entry-level monopolar RF tightening box that Cynosure reps love to bundle into multi-device deals, and it does exactly what cheap RF does: mild, temporary collagen stimulation that photographs poorly and retains clients decently. No consumables, nearly idiot-proof to delegate, and pencils out fine as a membership/add-on service — but do not buy it expecting an Ultherapy or Thermage competitor. Buy it used or as a throw-in on a Potenza/Elite iQ package; paying full list for a standalone Envi is how medspas end up with a coat rack. As a recurring-revenue "toning facial" workhorse under a membership model, it earns its keep.

Overview

No-downtime facial tightening; also surgical handpieces

How it works

The science

300-watt monopolar RF at 4MHz through small (10-20mm) handpieces with a return pad, bulk-heating dermis to ~42-45C and holding it via the Therapeutic Logic Control timer to trigger collagen denaturation and neocollagenesis. Cleared use: non-ablative treatment of mild-to-moderate facial wrinkles and rhytids; body attachments (FlexSure wraps, TempSure Firm head) add soft-tissue heating and temporary cellulite-appearance work. Painless, no-downtime, 30-45 minutes, series of 4-6 plus maintenance — results real but subtle, skewing "skin quality" over visible lifting. Best responders: thin-skinned patients late 30s-50s with early laxity; it will disappoint significant jowling.

Patented tech

Therapeutic Logic Control (TLC) reads tissue impedance/temperature and starts the treatment timer only once target temp is reached — genuinely useful for consistency across operators, but it's a control algorithm, not a new energy source. The 4MHz "less impedance, more comfort" claim is standard monopolar physics dressed in marketing.

Origin

Westford, Massachusetts (Cynosure, now Cynosure Lutronic) — genuinely US-built.

FDA & regulatory status

FDA status under reviewRegulatory status not yet verified

What it's actually cleared for:

Current clearance K223292 (Cynosure LLC, November 2022, verified) — non-ablative treatment of mild-to-moderate facial wrinkles/rhytids plus tissue heating and temporary cellulite-appearance reduction; original platform cleared 2017. "Skin tightening" on the body is off-label marketing shorthand.

Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.

Treatment economics

What practices charge

~$200-500 per facial session, $400-800 neck/body, 4-6 session packages ($1,000-2,500) with quarterly maintenance; slots naturally into $150-300/month memberships. Revenue per hour is modest — profitability depends on delegating to an aesthetician where state law allows.

Consumables & recurring cost

Effectively none — reusable handpieces, grounding pad, conductive gel. Annual disposable spend negligible — the single best argument for owning one.

Ideal for

Best-fit practice

Established medspas needing a painless, delegate-able retention service for 35-60-year-olds not ready for needles or downtime. Poor fit as a first or only device — it cannot headline a menu. Works best where injectable traffic already exists to cross-sell.

Compliance

Medical director & delegation

Non-ablative RF commonly delegated to RNs or aestheticians under standing orders, but delegation varies hard by state; you still need a medical director and good-faith exams where required.

Contraindications & screening

Implanted electronic devices (hard no for monopolar RF), pregnancy, metal implants in the field, active skin disease at the site. RF is color-blind — safe across Fitzpatrick types.

Ownership

Warranty & service

1-year standard; extended ~$5-10k/year; Cynosure's post-merger service turbulence is documented — budget for slow field response in some regions and get loaner terms in writing. The box itself is simple and reliable.

Resale & used market

Plentiful at ~$12-30k used against $50-75k negotiated new — steep depreciation because supply is high. Bad for sellers, excellent for buyers; a certified-refurb Envi is one of the better value plays in RF.