Identity
- Trade Name
- Luma Blemish FDA UDI
- Generic Name
- Red/blue light phototherapy unit FDA UDI
- Device Name
- Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris FDA UDI
- Model / Reference
- TN2197 FDA UDI
- Description
- Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060534510685 FDA UDI
- 510(k) Number
- K231555 FDA UDI
- FDA Product Code
- OLP FDA UDI
- GMDN Term
- Red/blue light phototherapy unit 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: Red/blue light phototherapy unit
Luma Blemish by iSMART Developments, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231555 also covers:
- Dr Sabrina Eye Regenerate LED mask — iSMART Developments, Ltd.
- Lightmax mini pro Eyeconic LED — iSMART Developments, Ltd.
- Luma Revive — iSMART Developments, Ltd.
- Omnilux Blemish Eraser — iSMART Developments, Ltd.
- Omnilux Eye Brightener — iSMART Developments, Ltd.
- SMOOTHSKIN DuoLux Mini Collagen+ LED Eye Patches — 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 3a896921-4856-4497-b724-ed5912457caf 34 fields · synced May 30, 2026