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Lumenx Model GAT-577 Pulsed Dye Laser

by Phase-R Corp.

510(k) K871206

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 NumberK871206 Date22 Jul 1987ClearedStatusActive

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  • Withdrawn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)

Full name
Lumenx Model Gat-577 Photocoagu. Pulsed Dye Laser
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 Lumenx Model GAT-577 Pulsed Dye Laser is a medical device classified as a Pulsed Dye Laser (Device Type: GEX), designed for photocoagulation procedures. It emits pulsed light at a specific wavelength to target vascular lesions, such as port wine stains, through selective photothermolysis. The device delivers controlled energy to coagulate blood vessels while minimizing damage to surrounding tissue.

This device is supplied as a reusable medical instrument and requires proper sterilization between uses. It is intended for use in clinical settings, including dermatology and plastic surgery, and must comply with FDA 510(k) clearance (K871206). No specific MRI safety classification or sterility guarantee is stated in the data. Storage and handling must adhere to manufacturer guidelines to ensure functionality and safety.

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 vascular lesions is the Lumenx Model GAT-577 Pulsed Dye Laser specifically designed to treat?

    The Lumenx Model GAT-577 is designed for photocoagulation procedures targeting vascular lesions like port wine stains. It uses pulsed light at a specific wavelength to selectively coagulate blood vessels through a process called selective photothermolysis, which helps minimize damage to surrounding tissue.

  • Is the Lumenx Model GAT-577 Pulsed Dye Laser a single-use device or reusable, and what sterilization requirements apply?

    The Lumenx Model GAT-577 is a reusable medical instrument, meaning it must be properly sterilized between uses to maintain safety and functionality. Sterilization procedures should follow the manufacturer’s guidelines to ensure compliance with clinical standards.

  • What clinical specialties commonly use the Lumenx Model GAT-577 Pulsed Dye Laser, and why?

    This device is primarily used in dermatology and plastic surgery settings. Its design targets vascular lesions like port wine stains, making it a specialized tool for procedures where precise coagulation of blood vessels is required while preserving adjacent tissue.

  • How was the FDA clearance for the Lumenx Model GAT-577 Pulsed Dye Laser determined, and what does that mean for its regulatory status?

    The device received FDA clearance through a 510(k) submission (K871206) with a decision labeled as *Substantially Equivalent* (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, confirming its compliance with regulatory requirements for photocoagulation lasers in clinical use.