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Celluma CLEAR C/US

by BioPhotas, Inc.

Celluma CLEAR C/US (CLTC-001) is a Class II device made by BioPhotas, Inc., cleared under FDA 510(k) K171323 on 1 Sep 2017 and listed in FDA GUDID since 11 Jun 2020 (UDI-DI 00850523007037), 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) K171323

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 Number00850523007037 UDI-DI Date11 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK171323 Date1 Sep 2017IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171323 decided 1 Sep 2017 Active
  • FDA GUDID UDI-DI 00850523007037 listed 11 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171323
  2. Listed FDA GUDID 00850523007037

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Celluma
Generic name
Blue/red/infrared phototherapy lamp
Model / Ref / Catalog
CLEAR C/US, CLTC-001
Primary DI / UDI-DI
00850523007037
510(k) Number
FDA product code
OHS, OLP
GMDN term
Blue/red/infrared phototherapy lamp
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blue/red/infrared phototherapy lamp

Cleared under the same submission (K171323)

and 8 more cleared under K171323

Similar devices

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

Other devices from BioPhotas, Inc.

See all devices from BioPhotas, Inc. →

Properties

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