Lucent : IPL
by Luvo Medical Technologies Inc
510(k) K193072
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193072 | Date5 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K193072
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ONF
- FDA applicant
- Luvo Medical Technologies, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
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.
Devices cleared under K193072
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Lucent IPL ESM-9200IL | ESM-9200IL | 00754016214004 | — | On the market |
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