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Adept 1064/532/755 Laser

by Adept Medical Concepts

510(k) K032218

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 NumberK032218 Date24 Oct 2003ClearedStatusActive

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  • Withdrawn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, 26 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 Adept 1064/532/755 Laser is a medical device that operates at multiple wavelengths for various applications. At 755 nm, it is used for the coagulation and hemostasis of vascular lesions and for the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin types. At 1064 nm, it is intended for general surgical applications including incision, excision, coagulation, and hemostasis.

The device is supplied by Adept Medical Concepts and has received FDA 510(k) clearance with K-number K032218. It is classified under product code GEX and was reviewed by the General and Plastic Surgery advisory committee. The device is not indicated as MRI safe, and no information is provided regarding sterility, single-use or reusable status, or specific storage requirements.

Other devices from Adept Medical Concepts

Questions

AI-generated answers, 26 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 are the primary applications of the Adept 1064/532/755 Laser?

    The Adept Laser operates at three wavelengths: 755 nm for coagulation of vascular lesions and permanent hair reduction in all skin types, and 1064 nm for general surgical applications including incision, excision, coagulation, and hemostasis.

  • What is the regulatory status of the Adept 1064/532/755 Laser?

    The device has received FDA 510(k) clearance with K-number K032218, classified under product code GEX, and was reviewed by the General and Plastic Surgery advisory committee. It is not indicated as MRI safe.

  • Is the Adept 1064/532/755 Laser supplied sterile and is it single-use or reusable?

    The device data does not specify whether the Adept Laser is supplied sterile or if it is designed for single-use or multiple reuse. This information should be obtained directly from the manufacturer, Adept Medical Concepts.

  • Are there specific storage requirements for the Adept 1064/532/755 Laser?

    No specific storage requirements are provided in the device data. Users should consult the manufacturer's instructions for proper storage conditions to maintain device functionality and safety.