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Accu-Beam Laser Block 301513BG385/Beam Splitters 301513BG39

by Transamerican Technologies Intl.

510(k) K963193

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 NumberK963193 Date13 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  • Withdrawn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, 23 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 device is a laser surgical instrument for use in general and plastic surgery and in dermatology. It is identified as a carbon dioxide laser intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide, and may also function as an argon laser intended to destroy or coagulate tissue by light energy.

The device received FDA 510(k) clearance under K963193 on November 13, 1996, and was found substantially equivalent to a predicate device. It is manufactured by Transamerican Technologies Intl. and classified under product code GEX with advisory committee review in General, Plastic Surgery (SU).

Other devices from Transamerican Technologies Intl.

Questions

AI-generated answers, 23 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 ACCU-BEAM Laser Block 301513BG385/Beam Splitters 301513BG39 used for?

    It is a laser surgical instrument intended for use in general and plastic surgery and dermatology to cut, destroy, or remove tissue using light energy from a carbon dioxide laser, and may also function as an argon laser to destroy or coagulate tissue.

  • How was the ACCU-BEAM Laser Block 301513BG385/Beam Splitters 301513BG39 cleared for market?

    It received FDA 510(k) clearance under K963193 on November 13, 1996, after being found substantially equivalent to a predicate device, based on a traditional review process.

  • Who manufactures the ACCU-BEAM Laser Block 301513BG385/Beam Splitters 301513BG39 and where are they located?

    The device is manufactured by Transamerican Technologies Intl., located at 7026 Koll Center Pkwy, Suite 207, Pleasanton, CA 94566, United States.

  • What product code and advisory committee classification apply to the ACCU-BEAM Laser Block 301513BG385/Beam Splitters 301513BG39?

    It is classified under product code GEX and was reviewed by the General, Plastic Surgery (SU) advisory committee, indicating its filing category for surgical laser devices.