7ls

FDA UDI

Class II (US FDA UDI)

by Fka Distributing Co., Llc

Identity

Trade Name: 7LS FDA UDI
Generic Name: Red/blue light phototherapy unit FDA UDI
Device Name: ReNew Light Therapy FDA UDI
Model / Reference: FA7-1450J FDA UDI
Description: ReNew Light Therapy FDA UDI

Identifiers

Catalog Number: FA7-1450J FDA UDI
Primary DI / UDI-DI: 00031262096265 FDA UDI
510(k) Number: K162098 FDA UDI
FDA Product Code: OHS FDA UDI
OLP FDA UDI
GMDN Term: Red/blue light phototherapy unit 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Red/blue light phototherapy unit

7ls by Fka Distributing Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Fka Distributing Co., Llc

Sources (1)

FDA UDI 99b1a3b2-47db-4ba5-b6ae-e6b7ef51d5a3 36 fields · synced Jun 8, 2026