Skip to content

Pdt-Face

by Beijing ADSS Development Co., Ltd.

Pdt-Face is a Class II device made by Beijing ADSS Development Co., Ltd., cleared under FDA 510(k) K192295 on 1 May 2020 and listed in FDA GUDID since 30 Aug 2022 (UDI-DI 06970453270005), active as of 21 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 21 Oct 2026

Documents

510(k) K192295

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06970453270005 UDI-DI Date30 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192295 Date1 May 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192295 decided 1 May 2020 Active
  • FDA GUDID UDI-DI 06970453270005 listed 30 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192295
  2. Listed FDA GUDID 06970453270005

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Red/blue light phototherapy unit
Model / reference
PDT-FACE
Primary DI / UDI-DI
06970453270005
510(k) Number
FDA product code
OLP, OHS
GMDN term
Red/blue light phototherapy unit
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Red/blue light phototherapy unit

Similar devices

Other devices filed under FDA product code OLP (Over-The-Counter Powered Light Based Laser For Acne).

Other devices from Beijing ADSS Development Co., Ltd.

See all devices from Beijing ADSS Development Co., Ltd. →

Properties

  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)