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Valeda Light Delivery System

by Lumithera, Inc.

De Novo DEN230083

Active United States. Also listed in GUDID (US).

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 27 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, GUDID, synced 27 Oct 2026. What this means

Regulatory status

as of registry sync 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB749200002010 UDI-DI Date16 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA De NovoDENG De Novo De Novo granted · Direct NumberDEN230083 Date4 Nov 2024DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 27 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Specification

De Novo · GUDID

Generic Name
Red-light phototherapy unit, professional
Model / Reference
200002-01
Primary DI / UDI-DI
B749200002010
De Novo Number
FDA Product Code
SDE
GMDN Term
Red-light phototherapy unit, professional
Device Class
Class II
Regulation
21 CFR Part 886.5520
Advisory Committee
Ophthalmic
FDA Decision
DENG De Novo granted
GUDID distribution status
In Commercial Distribution

Other devices from Lumithera, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No