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Tanda Series 4

by Tanda Beauty Canada, Inc 3 variants

Tanda Series 4 (HU-FG00961) is a red/blue light phototherapy unit (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Tanda Beauty Canada, Inc, cleared under FDA 510(k) K080591 on 14 Nov 2008 and listed in FDA GUDID since 2 Oct 2017 (UDI-DI 00806248005186), 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) K080591

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 Number00806248005186 UDI-DI Date2 Oct 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK080591 Date14 Nov 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K080591 decided 14 Nov 2008 Active
  • FDA GUDID UDI-DI 00806248005186 listed 2 Oct 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K080591
  2. Listed FDA GUDID 00806248005186

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tanda
Generic name
Red/blue light phototherapy unit
Model / Ref / Catalog
Series 4, HU-FG00961
Primary DI / UDI-DI
00806248005186
510(k) Number
FDA product code
GEX
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 (K080591)

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Tanda Beauty Canada, Inc

See all devices from Tanda Beauty Canada, Inc →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)