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Flex-Lase 600 Series Ion Laser System

by American Laser Medical

510(k) K963389

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 NumberK963389 Date26 Nov 1996ClearedStatusActive

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  • Withdrawn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, 1 Oct 2026

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

The Flex-Lase 600 Series Ion Laser System is a powered laser surgical instrument designed for dermatological applications. It emits laser light at a selected wavelength to target and photocoagulate vascular and pigmented lesions in the skin, leveraging the absorption characteristics of specific tissue chromophores. This device operates within the scope of general and plastic surgery procedures, providing precise tissue interaction for controlled treatment outcomes. Its classification aligns with FDA’s powered laser instruments for surgical use.

This system is supplied as a reusable medical device, intended for use in clinical settings where vascular or pigmented skin lesions require targeted laser therapy. The Flex-Lase 600 Series holds an FDA 510(k) clearance (K963389) under the General & Plastic Surgery advisory committee, with a decision date of November 26, 1996. No specific sterility or single-use designation is noted in the regulatory filing, though standard surgical laser precautions apply. Storage and maintenance should adhere to manufacturer guidelines for laser systems to ensure proper functionality and safety.

Other devices from American Laser Medical

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Flex-Lase 600 Series Ion Laser System used for?

    The Flex-Lase 600 Series Ion Laser System is designed for dermatological applications, specifically targeting and photocoagulating vascular and pigmented lesions in the skin. It uses laser light at a selected wavelength to interact with tissue chromophores, enabling precise and controlled treatment outcomes during general and plastic surgery procedures. This makes it suitable for clinical settings where targeted laser therapy is required for skin lesion management.

  • Is the Flex-Lase 600 Series Ion Laser System single-use or reusable?

    The Flex-Lase 600 Series Ion Laser System is supplied as a reusable medical device. While no explicit sterility designation is noted in the regulatory filing, it is intended for use in clinical settings where standard surgical laser precautions apply. Proper maintenance and adherence to manufacturer guidelines are essential to ensure functionality and safety during reuse.

  • How should the Flex-Lase 600 Series Ion Laser System be stored?

    Storage and maintenance of the Flex-Lase 600 Series Ion Laser System should follow the manufacturer’s guidelines for laser systems. These typically include protecting the device from physical damage, ensuring it is kept in a clean and dry environment, and following any specific protocols for calibration or servicing. Proper storage is critical to maintaining performance and safety over repeated use.

  • What regulatory clearance does the Flex-Lase 600 Series Ion Laser System hold?

    The Flex-Lase 600 Series Ion Laser System holds an FDA 510(k) clearance (K963389) under the General & Plastic Surgery advisory committee. The clearance was granted on November 26, 1996, and the device is classified as substantially equivalent to predicate laser systems for surgical use. This clearance confirms its compliance with FDA requirements for powered laser instruments in dermatological applications.

  • What types of lesions can the Flex-Lase 600 Series Ion Laser System treat?

    The Flex-Lase 600 Series Ion Laser System is specifically designed to target vascular and pigmented lesions in the skin. Its wavelength is optimized for photocoagulation, allowing it to selectively interact with tissue chromophores associated with these types of lesions. This precision helps clinicians achieve controlled treatment outcomes during dermatological procedures.