Shani Darden LED Light Therapy Mask

FDA UDI

Class II (US FDA UDI)

by iSMART Developments, Ltd.

Identity

Trade Name: Shani Darden LED Light Therapy Mask FDA UDI
Generic Name: Blue/red/infrared phototherapy lamp FDA UDI
Device Name: Shani Darden Branded Facemask Blue, Red & NIR facemask FDA UDI
Model / Reference: TN2118 FDA UDI
Description: Shani Darden Branded Facemask Blue, Red & NIR facemask FDA UDI

Identifiers

Catalog Number: 115-HGSD FDA UDI
Primary DI / UDI-DI: 05060534510517 FDA UDI
510(k) Number: K214103 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

Yes

FDA UDI

Category: Blue/red/infrared phototherapy lamp

Shani Darden LED Light Therapy Mask by iSMART Developments, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blue/red/infrared phototherapy lamp.

Dermalux — Aesthetic Technology, Ltd. · Class II
Celluma — BioPhotas, Inc. · Class II
reVive Light Therapy® — LED TECHNOLOGIES, INC. · Class II
Dr Dennis Gross Skincare — LED TECHNOLOGIES, INC. · Class II
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

Cleared under the same submission

K214103 also covers:

EOS X by Deesse Pro — iSMART Developments, Ltd.

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: iSMART Developments, Ltd.

Sources (1)

FDA UDI a3f7bf6c-dca1-4de8-904b-d8dbccff28e0 36 fields · synced Jun 8, 2026