Identity
- Trade Name
- Luna 4 Plus FDA UDI
- Generic Name
- Blue/red/infrared phototherapy lamp FDA UDI
- Device Name
- Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage Microcurrent: indicated for facial stimulation RED+IR: indicated for treat periorbital wrinkle FDA UDI
- Model / Reference
- Pink FDA UDI
- Description
- Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent Massage Microcurrent: indicated for facial stimulation RED+IR: indicated for treat periorbital wrinkle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350120791245 FDA UDI
- 510(k) Number
- K241102 FDA UDI
- FDA Product Code
- OHS FDA UDINFO FDA UDI
- GMDN Term
- Blue/red/infrared phototherapy lamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI882.5890 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Physical therapy transcutaneous neuromuscular electrical stimulation systemBlue/red/infrared phototherapy lamp
Luna 4 Plus by Foreo Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K241102 also covers:
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
- Foreo Inc
Sources (1)
- FDA UDI 2b722db0-ad24-400f-91e6-0d8446abdef8 34 fields · synced Jun 6, 2026