Skip to content

Emvital

by BTL Industries, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB108043POEMVMUS00 UDI-DI Date19 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Red-light phototherapy unit, professional
Model / Reference
EMVITAL
Primary DI / UDI-DI
B108043POEMVMUS00
FDA Product Code
ILY
GMDN Term
Red-light phototherapy unit, professional
Device Class
Class II
Regulation Number
890.5500
GUDID distribution status
In Commercial Distribution

Other devices from BTL Industries, Inc.

See all devices from BTL Industries, Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

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