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Surgi Light Nd:Yag Laser System Model 904030

by Surgical Laser Products, Inc.

510(k) K915768

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 NumberK915768 Date11 Feb 1992ClearedStatusActive

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  • Withdrawn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, 21 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 Surgi Light Nd:Yag Laser System Model 904030 is a laser device designed for surgical applications. It utilizes Nd:Yag laser technology to perform clinical procedures.

This device is authorized via FDA 510K clearance. It is categorized under the product code GEX for use in general and plastic surgery settings.

Questions

AI-generated answers, 21 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 is the intended clinical use for the Surgi Light Nd:Yag Laser System?

    The Surgi Light Nd:Yag Laser System Model 904030 is designed for surgical applications. It is specifically categorized under product code GEX, which indicates its intended use within general and plastic surgery settings.

  • What is the regulatory status of this laser system?

    The Surgi Light Nd:Yag Laser System Model 904030 has received FDA 510K clearance. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

  • Who is the manufacturer of the Model 904030 laser system?

    This device is manufactured by Surgical Laser Products, Inc., located in North Attleboro, Massachusetts.