The following data is part of a premarket notification filed by Lutronic Global with the FDA for Lasemd Leo Laser System.
| Device ID | K192331 |
| 510k Number | K192331 |
| Device Name: | LaseMD LEO Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lutronic Global 19 Fortune Drive Billerica, MA 01821 |
| Contact | James Childs |
| Correspondent | James Childs Lutronic Global 19 Fortune Drive Billerica, MA 01821 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-27 |
| Decision Date | 2019-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809447653990 | K192331 | 000 |
| 08809447653112 | K192331 | 000 |
| 08809447653129 | K192331 | 000 |
| 08809447653136 | K192331 | 000 |
| 08809447653143 | K192331 | 000 |
| 08809447653150 | K192331 | 000 |
| 08809447653181 | K192331 | 000 |
| 08809447653198 | K192331 | 000 |
| 08809447653204 | K192331 | 000 |
| 08809447653044 | K192331 | 000 |
| 08809447653068 | K192331 | 000 |
| 08809447653075 | K192331 | 000 |
| 08809447653082 | K192331 | 000 |
| 08809447653099 | K192331 | 000 |
| 08809447654010 | K192331 | 000 |
| 08809447653105 | K192331 | 000 |