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Atl Atl-250

by Advanced Technology Laser Co., Ltd.

Atl Atl-250 is a Class II device made by Advanced Technology Laser Co., Ltd., cleared under FDA 510(k) K083918 on 2 Feb 2009 and listed in FDA GUDID since 26 Oct 2016 (UDI-DI 06970507240114), active as of 22 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 22 Oct 2026

Documents

510(k) K083918

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970507240114 UDI-DI Date26 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083918 Date2 Feb 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083918 decided 2 Feb 2009 Active
  • FDA GUDID UDI-DI 06970507240114 listed 26 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083918
  2. Listed FDA GUDID 06970507240114

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Atl
Generic name
Dermatological carbon dioxide laser system
Model / reference
ATL-250
Primary DI / UDI-DI
06970507240114
510(k) Number
FDA product code
GEX
GMDN term
Dermatological carbon dioxide laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Dermatological carbon dioxide laser system

Cleared under the same submission (K083918)

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Advanced Technology Laser Co., Ltd.

  • ATL Angelite-DDC

    Class II

  • Atl Atl-150

    Class II

  • ATL GlobalCure-SC6

    Class II

  • ATL eBeam

    Class II

See all devices from Advanced Technology Laser Co., Ltd. →

Properties

  • Single use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)