Skip to content

Accu-Beam 7062

by Transamerican Technologies International

Accu-Beam 7062 is a Class II device made by Transamerican Technologies International, cleared under FDA 510(k) K864378 on 5 Mar 1987 and listed in FDA GUDID since 16 Jun 2016 (UDI-DI B17770620), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K864378

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB17770620 UDI-DI Date16 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK864378 Date5 Mar 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K864378 decided 5 Mar 1987 Active
  • FDA GUDID UDI-DI B17770620 listed 16 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K864378
  2. Listed FDA GUDID B17770620

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Accu-Beam
Generic name
Laser adaptor
Model / reference
7062
Primary DI / UDI-DI
B17770620
510(k) Number
FDA product code
HHR
GMDN term
Laser adaptor
Device class
Class II
Regulation number
884.4550
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code HHR (Laser, Surgical, Gynecologic).

Other devices from Transamerican Technologies International

See all devices from Transamerican Technologies International →

Properties

Other properties (15, all answered No)