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Finebeam

by Snj Co., Ltd

Finebeam is a Class II device made by Snj Co., Ltd, cleared under FDA 510(k) K202288 on 19 Nov 2021 and listed in FDA GUDID since 10 May 2023 (UDI-DI 08800086000077), active as of 8 Jun 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 8 Jun 2026

Documents

510(k) K202288

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800086000077 UDI-DI Date10 May 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202288 Date19 Nov 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202288 decided 19 Nov 2021 Active
  • FDA GUDID UDI-DI 08800086000077 listed 10 May 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202288
  2. Listed FDA GUDID 08800086000077

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dermatological frequency-doubled solid-state laser system
Model / reference
Finebeam
Primary DI / UDI-DI
08800086000077
510(k) Number
FDA product code
GEX
GMDN term
Dermatological frequency-doubled solid-state laser system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Dermatological frequency-doubled solid-state laser system.

Other devices from Snj Co., Ltd

  • Finebeam

    Class II
  • N-Pulse FX

    Class IIb
  • Finexel

    Class IIb

Properties

  • Serial number
Other properties (14, all answered No)