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Aura Wellness ROC

by Aura Wellness, LLC

Aura Wellness ROC is a red/infrared light phototherapy unit (FDA Class II; FDA product code ILY, Lamp, Infrared, Therapeutic Heating) made by Aura Wellness, LLC, listed in FDA GUDID since 21 Jul 2026 (UDI-DI 00850026680218), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850026680218 UDI-DI Date21 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Aura Wellness
Generic name
Red/infrared light phototherapy unit
Model / Ref / Catalog
ROC
Primary DI / UDI-DI
00850026680218
FDA product code
ILY
GMDN term
Red/infrared light phototherapy unit
Device class
Class II
Regulation number
890.5500
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code ILY (Lamp, Infrared, Therapeutic Heating).

Other devices from Aura Wellness, LLC

See all devices from Aura Wellness, LLC →

Properties

  • Over-the-counter
  • Convenience kit
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)