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Luminance RED Mouth Device

FDA UDI

Class II (US FDA UDI)

by Luminance Medical Ventures Incorporated

Identity

Trade Name
Luminance RED Mouth Device FDA UDI
Generic Name
Musculoskeletal/physical therapy laser, home-use FDA UDI
Model / Reference
TN1927B FDA UDI

Identifiers

Primary DI / UDI-DI
00860002593043 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal/physical therapy laser, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Musculoskeletal/physical therapy laser, home-use

Luminance RED Mouth Device by Luminance Medical Ventures Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Musculoskeletal/physical therapy laser, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Luminance Medical Ventures Incorporated

Sources (1)

  • FDA UDI 3a63702f-148f-4eb3-ab3b-2bece58ceb3b 32 fields · synced May 30, 2026