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CARELight

FDA UDI

Class II (US FDA UDI)

by Healthlight Llc

Identity

Trade Name
CARELight FDA UDI
Generic Name
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Device Name
90-LED Red/IR CAREPad - Infrared Phototherapy Device FDA UDI
Model / Reference
CL-90R FDA UDI
Description
90-LED Red/IR CAREPad - Infrared Phototherapy Device FDA UDI

Identifiers

Catalog Number
602011 FDA UDI
Primary DI / UDI-DI
00858935006389 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal infrared phototherapy unit, non-wearable 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Musculoskeletal infrared phototherapy unit, non-wearable

CARELight by Healthlight Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Musculoskeletal infrared phototherapy unit, non-wearable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Healthlight Llc

Sources (1)

  • FDA UDI fd3aba1b-112d-48b8-9378-00af8f311546 34 fields · synced Jun 6, 2026