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Aesthera Photopneumatic (PPX) System

by Aesthera Corporation

510(k) K062048

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062048 Date7 Sep 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aesthera Photopneumatic (PPX) System is a device that combines pneumatic energy and broadband light for dermatological applications. It is designed to deliver light energy to the skin to encourage collagen production, offering a non-laser, non-intense pulsed light alternative for skin treatment.

The system is supplied as a reusable device intended for use in clinical settings such as plastic and cosmetic surgery practices. It received FDA 510(k) clearance (K062048) on September 7, 2006, as substantially equivalent to predicate devices, and is authorized for marketing in the United States under product code GEX.

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