The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Resurfx 1565nm Laser Module.
| Device ID | K130028 |
| 510k Number | K130028 |
| Device Name: | RESURFX 1565NM LASER MODULE |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | LUMENIS, LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy LUMENIS, LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-03 |
| Decision Date | 2013-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143040 | K130028 | 000 |
| 07290109140377 | K130028 | 000 |