The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Lasemd Laser System.
| Device ID | K171009 |
| 510k Number | K171009 |
| Device Name: | LASEMD Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lutronic Corporation 219, Sowon-ro, Haengsin-dong Deogyang-gu, Goyang-si, KR 410-220 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir Lutronic Corporation 6 Neshaminy Interplex, Suite 100 Trevose, PA 19053 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2017-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809447652009 | K171009 | 000 |
| 08809447651996 | K171009 | 000 |
| 08809447651989 | K171009 | 000 |
| 08809447651972 | K171009 | 000 |
| 08809447651965 | K171009 | 000 |