The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for M22 And Resurfx Systems.
| Device ID | K170060 |
| 510k Number | K170060 |
| Device Name: | M22 And ResurFx Systems |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, LTD. 6 HAKIDMA STREET PO Box 240 Yokneam, IL 2069204 |
| Contact | Naama Jacoby |
| Correspondent | Naama Jacoby LUMENIS, LTD. 6 HAKIDMA STREET PO Box 240 Yokneam, IL 2069204 |
| Product Code | GEX |
| Subsequent Product Code | ONF |
| Subsequent Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-06 |
| Decision Date | 2017-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290117772218 | K170060 | 000 |
| 07290117772201 | K170060 | 000 |