The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Clarity Lpc Laser System.
| Device ID | K130199 |
| 510k Number | K130199 |
| Device Name: | CLARITY LPC LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 Trevose, PA 19053 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 207 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 | 2013-01-28 |
| Decision Date | 2013-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809447652184 | K130199 | 000 |
| 08809447651491 | K130199 | 000 |
| 08809447651484 | K130199 | 000 |
| 8809447651477 | K130199 | 000 |
| 08809447651453 | K130199 | 000 |
| 08809447651446 | K130199 | 000 |
| 8809447651439 | K130199 | 000 |
| 8809447651415 | K130199 | 000 |
| 8809447651767 | K130199 | 000 |