The following data is part of a premarket notification filed by Luvo Medical Technologies, Inc. with the FDA for Lucent : Ipl.
| Device ID | K193072 |
| 510k Number | K193072 |
| Device Name: | Lucent : IPL |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | LUVO Medical Technologies, Inc. 125 Fleming Dr Cambridge, CA N1t 2b8 |
| Contact | Gregory Berzak |
| Correspondent | Gregory Berzak LUVO Medical Technologies, Inc. 125 Fleming Dr Cambridge, CA N1t 2b8 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-04 |
| Decision Date | 2020-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754016214004 | K193072 | 000 |