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Model 545-45 Laser for Derma., Pod., Surgical

by Britt Corp., Inc. 510(k)

Active United States

510(k) K860974

Overview

The Model 545-45 Laser is a carbon dioxide laser device intended for use in general surgery, dermatology, and podiatry. It operates by emitting light energy to cut, destroy, or remove tissue during medical procedures.

This device is supplied by Britt Corp., Inc. and is classified as a powered laser surgical instrument under product code GEX. It received FDA 510(k) clearance on July 7, 1986, with the model number K860974. The device is intended for use in clinical settings by trained medical professionals.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860974 Date7 Jul 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Model 545-45 Laser used for?

    The Model 545-45 Laser is a carbon dioxide laser device intended for use in general surgery, dermatology, and podiatry procedures. It operates by emitting light energy to cut, destroy, or remove tissue during medical procedures.

  • How is the Model 545-45 Laser supplied?

    The device is supplied by Britt Corp., Inc. and is classified as a powered laser surgical instrument under product code GEX. It is intended for use in clinical settings by trained medical professionals.

  • What is the regulatory status of the Model 545-45 Laser?

    The Model 545-45 Laser received FDA 510(k) clearance on July 7, 1986, with the model number K860974. It is classified as substantially equivalent under decision code SESE and was reviewed by the General, Plastic Surgery advisory committee.

  • Is the Model 545-45 Laser reusable or single-use?

    The device data does not specify whether the Model 545-45 Laser is designed for single-use or multiple uses. This information would be detailed in the device's specific instructions for use provided by the manufacturer.