Skip to content

Ipl Therapy Machine VE2000

by Beijing ADSS Development Co., Ltd.

Ipl Therapy Machine VE2000 is an intense pulsed light skin surface treatment system (FDA Class II; FDA product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect) made by Beijing ADSS Development Co., Ltd., cleared under FDA 510(k) K161286 on 4 Aug 2016 and listed in FDA GUDID since 9 Apr 2018 (UDI-DI 06970453270043), 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) K161286

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 Number06970453270043 UDI-DI Date9 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161286 Date4 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161286 decided 4 Aug 2016 Active
  • FDA GUDID UDI-DI 06970453270043 listed 9 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161286
  2. Listed FDA GUDID 06970453270043

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ipl Therapy Machine
Generic name
Intense pulsed light skin surface treatment system
Model / reference
VE2000
Primary DI / UDI-DI
06970453270043
510(k) Number
FDA product code
ONF
GMDN term
Intense pulsed light skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intense pulsed light skin surface treatment system

Similar devices

Other devices filed under FDA product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).

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)