XERF vs Thermage FLX: what each FDA clearance actually shows

XERF and Thermage FLX are both monopolar radiofrequency devices cleared by the FDA through the 510(k) pathway, under the same product code, GEI. XERF was cleared as K251327 (Lutronic Corporation, 11 August 2025); Thermage FLX was cleared earlier, as K170758 (Solta Medical, 22 September 2017). No published study has compared the two devices against each other. At SkinScience NY, XERF is performed — priced per area, from $1,000 for the lower face to $2,500 for full face & neck — alongside Virtue RF; Thermage is not offered here.

What each clearance says

XERF's clearance names its indication precisely: electrocoagulation and hemostasis in dermatologic and general surgical procedures. It does not name skin tightening. Thermage FLX's clearance, K170758, sits in the same device category and product code (GEI) as XERF's; its full listed indication is on the FDA record linked below.

What XERF's 510(k) compared it with

A 510(k) clearance does not require a clinical trial of its own. Instead, the manufacturer shows the FDA that the new device is substantially equivalent to an already-cleared predicate. XERF's 510(k) used Thermage FLX, K170758, as its predicate device, and the comparison behind that was bench testing — device specifications and performance testing — not a clinical study comparing results on patients.

What the one XERF study shows

One peer-reviewed study of XERF has been published, in Lasers in Medical Science in 2026 (Erlich, Dahan & Wolf): sixteen women, one session each, followed for three months. It measured a lift of the brow and eyelid of between 1.1 and 1.4 mm, and mild redness that cleared within one to two days in three of the sixteen. It was retrospective and had no control group.

Which one is right for you

That is a question for an in-person assessment, not a marketing comparison. At SkinScience NY, that assessment weighs XERF against Virtue RF for your degree of laxity; a practice offering Thermage would assess against its own device the same way. Neither this page nor the clearances above are a substitute for being examined.

Common questions

Sources

• FDA 510(k) K251327 (XERF clearance)
• FDA 510(k) K170758 (Thermage FLX clearance)
• Erlich, Dahan & Wolf, Lasers in Medical Science (2026)

This guide is general information, not medical advice, and does not replace an in-person assessment. Treatments described are performed by Alla Yusim, RN, MSN, FNP at Skin in Focus, LLC, 7819 Bay Parkway, Brooklyn, NY 11214.