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Luma Blemish TN2197

by iSMART Developments, Ltd.

Luma Blemish TN2197 is a red/blue light phototherapy unit (FDA Class II; FDA product code OLP, Over-The-Counter Powered Light Based Laser For Acne) made by iSMART Developments, Ltd., cleared under FDA 510(k) K231555 on 27 Jul 2023 and listed in FDA GUDID since 26 Oct 2023 (UDI-DI 05060534510685), 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) K231555

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 Number05060534510685 UDI-DI Date26 Oct 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK231555 Date27 Jul 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K231555 decided 27 Jul 2023 Active
  • FDA GUDID UDI-DI 05060534510685 listed 26 Oct 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231555
  2. Listed FDA GUDID 05060534510685

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Luma Blemish
Generic name
Red/blue light phototherapy unit
Model / reference
TN2197
Primary DI / UDI-DI
05060534510685
510(k) Number
FDA product code
OLP
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

Cleared under the same submission (K231555)

and 2 more cleared under K231555

Similar devices

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

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)