K223642 is an FDA 510(k) clearance for the LED Lip Perfector, model: ZC-05. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on March 9, 2023, 93 days after receiving the submission on December 6, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K223642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2022 |
| Decision Date | March 09, 2023 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ILY - Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |