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

by Britt Corp., Inc.

510(k) K860974

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 NumberK860974 Date7 Jul 1986ClearedStatusActive

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  • Withdrawn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
Models / Variants
545-45 Laser For Derma.
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 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.

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Questions

AI-generated answers, 24 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 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.