Identity
- Trade Name
- Dr Naomi FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles. FDA UDI
- Model / Reference
- MK-04 FDA UDI
- Description
- The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856957008022 FDA UDI
- FDA Product Code
- 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
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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blue/red/infrared phototherapy lamp
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 Blue/red/infrared phototherapy lamp.
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- 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
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
- Shenzhen Kaiyan Medical Equipment Co, . Ltd
Sources (1)
- FDA UDI e07b1ca0-07e0-4ca9-9e8f-5b603ac5f932 33 fields · synced May 30, 2026