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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
CAREPad 180R Red-IR and controller Infrared LED Phototherapy System FDA UDI
Model / Reference
CL-180R-E FDA UDI
Description
CAREPad 180R Red-IR and controller Infrared LED Phototherapy System FDA UDI

Identifiers

Catalog Number
602032 FDA UDI
Primary DI / UDI-DI
00858935006631 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

Yes

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 94ad6ab0-f310-48b3-904f-473c4b936765 35 fields · synced May 30, 2026