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Positively Clear BL2

by Tria Laser Inc

Positively Clear BL2 (3374) is a blue-light phototherapy lamp (FDA Class II; FDA product code OLP, Over-The-Counter Powered Light Based Laser For Acne) made by Tria Laser Inc, cleared under FDA 510(k) K160821 on 15 Jun 2016 and listed in FDA GUDID since 26 Jan 2018 (UDI-DI B5863374), 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) K160821

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 NumberB5863374 UDI-DI Date26 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160821 Date15 Jun 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160821 decided 15 Jun 2016 Active
  • FDA GUDID UDI-DI B5863374 listed 26 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160821
  2. Listed FDA GUDID B5863374

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Positively Clear
Generic name
Blue-light phototherapy lamp, home-use
Model / Ref / Catalog
BL2, 3374
Primary DI / UDI-DI
B5863374
510(k) Number
FDA product code
OLP
GMDN term
Blue-light phototherapy lamp, home-use
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blue-light phototherapy lamp, home-use

Cleared under the same submission (K160821)

Similar devices

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

Other devices from Tria Laser Inc

See all devices from Tria Laser Inc →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)