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faceLITE TN2010

by iSMART Developments, Ltd.

faceLITE TN2010 (111A) is a Class II device made by iSMART Developments, Ltd., cleared under FDA 510(k) K191629 on 12 Sep 2019 and listed in FDA GUDID since 5 May 2021 (UDI-DI 05060534510012), 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) K191629

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 Number05060534510012 UDI-DI Date5 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191629 Date12 Sep 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191629 decided 12 Sep 2019 Active
  • FDA GUDID UDI-DI 05060534510012 listed 5 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191629
  2. Listed FDA GUDID 05060534510012

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
faceLITE
Generic name
Cosmetic red-light phototherapy system, home-use
Model / Ref / Catalog
TN2010, 111A
Primary DI / UDI-DI
05060534510012
510(k) Number
FDA product code
OHS
GMDN term
Cosmetic red-light phototherapy system, home-use
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cosmetic red-light phototherapy system, home-use

Cleared under the same submission (K191629)

and 8 more cleared under K191629

Similar devices

Other devices filed under FDA product code OHS (Light Based Over The Counter Wrinkle Reduction).

Other devices from iSMART Developments, Ltd.

See all devices from iSMART Developments, Ltd. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)