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Isolaz

by Aesthera Corporation

510(k) K083730

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 · Special NumberK083730 Date9 Jan 2009ClearedStatusActive

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  • Withdrawn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, 19 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 Isolaz is a laser device for skin treatment (Product Code: GEX), designed for non-invasive procedures to address acne and related skin conditions. It employs proprietary Photopneumatic technology to deliver controlled laser energy combined with pneumatic compression, targeting sebaceous glands and reducing inflammation.

Supplied as a reusable medical device, the Isolaz is intended for use in clinical settings by trained professionals. It requires FDA 510(k) clearance (K083730) under Special Review for General Plastic Surgery applications and is manufactured by Aesthera Corporation. No specific sterility or single-use designation is noted in the regulatory data.

Other devices from Aesthera Corporation

Questions

AI-generated answers, 19 Sep 2026

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

  • What types of skin conditions is the Isolaz laser device specifically designed to treat, and how does it work?

    The Isolaz is designed to address acne and related skin conditions through its proprietary Photopneumatic technology, which combines controlled laser energy with pneumatic compression. This approach targets sebaceous glands to reduce inflammation and improve skin texture, making it suitable for non-invasive clinical treatments in professional settings.

  • Is the Isolaz device single-use or reusable, and what does that mean for maintenance and cost?

    The Isolaz is reusable, meaning it is built for repeated use in clinical settings after proper cleaning and maintenance. This design reduces per-procedure costs compared to single-use devices, though facilities must follow manufacturer guidelines for sterilization and upkeep to ensure safety and performance.

  • How is the Isolaz device regulated, and what does its FDA clearance under Special Review imply for clinicians?

    The Isolaz received FDA 510(k) clearance (K083730) under Special Review for General Plastic Surgery (Product Code: GEX). This means it was deemed substantially equivalent to a legally marketed device, but the review process was more rigorous due to its innovative Photopneumatic technology. Clinicians should confirm compliance with the manufacturer’s instructions for safe and effective use.

  • What clinical settings or specialties would most benefit from using the Isolaz, and why?

    The Isolaz is most relevant for dermatologists, plastic surgeons, and aesthetic medicine practitioners who treat acne, inflammatory skin conditions, or sebaceous gland-related concerns. Its non-invasive, controlled energy delivery makes it ideal for procedures in dermatology clinics, medical spas, or plastic surgery offices where precise skin treatment is required.