Identifiers
- 510(k) Number
- K193072 FDA 510(k)
- FDA Product Code
- ONF 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 Lucent : IPL is a powered light-based non-laser surgical instrument with thermal effect, designed for multi-wavelength non-invasive skin treatments. It is used for the treatment of vascular and pigmented lesions, acne, age spots, and hair removal. The system utilizes multiple filters to reflect specific wavelengths of light to target different skin conditions.
The device is supplied by Luvo Medical Technologies Inc and is intended for professional use in clinical settings. It is a single-use or reusable system depending on the component, and should be stored according to manufacturer guidelines. The device has received FDA 510(k) clearance under K193072 and is classified under product code ONF. MRI safety information is not specified in the available data.
Frequently asked questions
What skin conditions does the Lucent : IPL treat?
The Lucent : IPL is designed for the treatment of vascular and pigmented lesions, acne, age spots, and hair removal. It uses multiple filters to reflect specific wavelengths of light to target different skin conditions.
Is the device single-use or reusable?
The device is a single-use or reusable system depending on the component. The manufacturer specifies which parts are disposable and which are reusable, so users should follow the component-specific guidelines provided with the system.
How is the device supplied?
The Lucent : IPL is supplied by Luvo Medical Technologies Inc. It is intended for professional use in clinical settings and should be stored according to manufacturer guidelines.
What is the regulatory status of the device?
The device has received FDA 510(k) clearance under K193072 and is classified under product code ONF. It is a Class II medical device.
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: Lucent Technologies – Wikipedia, LUVO - LUCENT IPL | Professional IPL Treatment, Lucent Technologies - Wikipedia, LUVO LUCENT™ - IPL Treatment Device - OCULUS, Inc., Lucent : IPL by LUVO Medical Technologies, Inc. | FDA 510(k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193072 | Class II | Active |
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Manufacturer
- Manufacturer
- Luvo Medical Technologies Inc
- FDA Applicant
- Luvo Medical Technologies, Inc.
Sources (1)
- FDA 510(k) K193072 24 fields · synced Sep 23, 2026