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 |