Identity
- Trade Name
- AURA FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- AURA Plus LED Light Therapy Mask FDA UDI
- Model / Reference
- FM-02 FDA UDI
- Description
- AURA Plus LED Light Therapy Mask FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974020960955 FDA UDI
- 510(k) Number
- K223544 FDA UDI
- FDA Product Code
- OHS FDA UDIOLP FDA UDIILY FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI890.5500 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blue/red/infrared phototherapy lamp
Aura by Guangdong Newdermo Biotech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blue/red/infrared phototherapy lamp.
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- LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
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- LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
- Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
Cleared under the same submission
K223544 also covers:
- AURA — Guangdong Newdermo Biotech Co., Ltd.
- INIA — Guangdong Newdermo Biotech Co., Ltd.
- Newdermo — Guangdong Newdermo Biotech Co., Ltd.
- VOGUENOW — Guangdong Newdermo Biotech Co., Ltd.
- VOGUENOW — Guangdong Newdermo Biotech Co., Ltd.
- WONDER FAMILY — Guangdong Newdermo Biotech Co., Ltd.
- WONDER FAMILY — Guangdong Newdermo Biotech Co., Ltd.
- kingdo — Guangdong Newdermo Biotech Co., Ltd.
- kingdo — Guangdong Newdermo Biotech Co., Ltd.
- Silk'n — Silk'N Beauty , Ltd.
- Silk'n — Silk'N Beauty , 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangdong Newdermo Biotech Co., Ltd.
Sources (1)
- FDA UDI 3800ee44-f380-4887-9022-6af5fd301860 35 fields · synced May 30, 2026