The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Lumenis Smart532 Laser System.
| Device ID | K151109 |
| 510k Number | K151109 |
| Device Name: | Lumenis Smart532 Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 1870 S MILESTONE DRIVE Salt Lake City, UT 84101 |
| Contact | Jayce R. Mclane |
| Correspondent | Jace Mclane LUMENIS, INC. 1870 S MILESTONE DRIVE Salt Lake City, UT 84101 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-27 |
| Decision Date | 2015-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143293 | K151109 | 000 |
| 00810096330079 | K151109 | 000 |
| 00810096330246 | K151109 | 000 |
| 00810096330253 | K151109 | 000 |
| 00810096330260 | K151109 | 000 |
| 00810096330277 | K151109 | 000 |
| 00810096330284 | K151109 | 000 |
| 00810096330291 | K151109 | 000 |
| 00810096330307 | K151109 | 000 |
| 00810096330314 | K151109 | 000 |
| 00810096330321 | K151109 | 000 |
| 00810096330338 | K151109 | 000 |
| 00810096330062 | K151109 | 000 |