LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231555 FDA 510(k)
- FDA Product Code
- OHS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LUMA LED patches are light-based over-the-counter devices that emit energy in the blue and red regions of the light spectrum. They are indicated to treat mild to moderate skin concerns. The device consists of two models: LUMA Blemish (TN2197) and LUMA Revive (TN2189).
The LUMA LED patches are supplied as Class II medical devices under product code OHS with FDA 510(k) clearance K231555. They are regulated under 878.4810 and were submitted by iSMART Developments, Ltd. of Birmingham, GB. The device is classified for light-based over-the-counter wrinkle reduction.
Frequently asked questions
What are the LUMA LED patches used for?
The LUMA LED patches are light-based over-the-counter devices that emit energy in the blue and red regions of the light spectrum. They are indicated to treat mild to moderate skin concerns, with two models available: LUMA Blemish (TN2197) and LUMA Revive (TN2189).
How are the LUMA LED patches supplied and what is their regulatory status?
The LUMA LED patches are supplied as Class II medical devices under product code OHS with FDA 510(k) clearance K231555. They are regulated under 878.4810 and were submitted by iSMART Developments, Ltd. of Birmingham, GB.
Are the LUMA LED patches single-use or reusable?
The device data does not specify whether the LUMA LED patches are single-use or reusable. This information would need to be obtained directly from the manufacturer or product instructions.
What sizes and models of LUMA LED patches are available?
The LUMA LED patches consist of two models: LUMA Blemish (TN2197) and LUMA Revive (TN2189). The device data does not provide specific size information for these models.
How should the LUMA LED patches be stored?
The device data does not specify storage requirements for the LUMA LED patches. Proper storage information would be included in the product instructions provided by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189 ..., K231555 FDA 510(k) - LUMA LED patches (LUMA Blemish (TN2197)..., LUMA LED patches (LUMA Blemish (TN2197) and LUMA… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231555 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- iSMART Developments, Ltd.
Sources (1)
- FDA 510(k) K231555 24 fields · synced Oct 6, 2026