Therabody

FDA UDI

Class II (US FDA UDI)

by Therabody, Inc.

Identity

Trade Name: Therabody FDA UDI
Generic Name: Blue/red/infrared phototherapy lamp FDA UDI
Device Name: TheraFace Mask Glo is the only one of its kind to help relax, restore and rejuvenate your skin. This mask combines504 full-face Red, Blue, and Red + Infrared LED lights FDA UDI
Model / Reference: TheraFace Mask Glo FDA UDI
Description: TheraFace Mask Glo is the only one of its kind to help relax, restore and rejuvenate your skin. This mask combines504 full-face Red, Blue, and Red + Infrared LED lights FDA UDI

Identifiers

Primary DI / UDI-DI: 00840295409672 FDA UDI
FDA Product Code: OLP FDA UDI
OHS FDA UDI
GMDN Term: Blue/red/infrared phototherapy lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Blue/red/infrared phototherapy lamp

Therabody by Therabody, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blue/red/infrared phototherapy lamp.

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LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Therabody, Inc.

Sources (1)

FDA UDI bba65167-a89b-4aad-8747-f77bb5ab209f 34 fields · synced May 30, 2026