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ESPADA 2 Cobalt Blue

by Foreo Inc

ESPADA 2 Cobalt Blue is a blue-light phototherapy lamp (FDA Class II; FDA product code OLP, Over-The-Counter Powered Light Based Laser For Acne) made by Foreo Inc, cleared under FDA 510(k) K162450 on 30 Nov 2016 and listed in FDA GUDID since 6 Aug 2024 (UDI-DI 07350120790538), 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) K162450

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 Number07350120790538 UDI-DI Date6 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162450 Date30 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162450 decided 30 Nov 2016 Active
  • FDA GUDID UDI-DI 07350120790538 listed 6 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162450
  2. Listed FDA GUDID 07350120790538

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Espada 2
Generic name
Blue-light phototherapy lamp, home-use
Model / reference
Cobalt Blue
Primary DI / UDI-DI
07350120790538
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 (K162450)

and 3 more cleared under K162450

Similar devices

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

Other devices from Foreo Inc

See all devices from Foreo Inc →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)