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Dr.naomi

FDA UDI

Class II (US FDA UDI)

by Shenzhen Kaiyan Medical Equipment Co, . Ltd

Identity

Trade Name
DR.NAOMI FDA UDI
Generic Name
Cosmetic red-light phototherapy system, home-use FDA UDI
Device Name
The LED Light Therapy Mask (Models: MK-78)is an over the counter device that is intended for the use in the treatment of full-face wrinkles. FDA UDI
Model / Reference
MK-78 FDA UDI
Description
The LED Light Therapy Mask (Models: MK-78)is an over the counter device that is intended for the use in the treatment of full-face wrinkles. FDA UDI

Identifiers

Primary DI / UDI-DI
00794712393542 FDA UDI
FDA Product Code
OHS FDA UDI
OLP FDA UDI
GMDN Term
Cosmetic red-light phototherapy system, home-use 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cosmetic red-light phototherapy system, home-use

Dr.naomi by Shenzhen Kaiyan Medical Equipment Co, . Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cosmetic red-light phototherapy system, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Kaiyan Medical Equipment Co, . Ltd

Sources (1)

  • FDA UDI 1a07258d-ff30-463d-83d6-72b05bc7a8e6 33 fields · synced May 31, 2026