The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity.
| Device ID | K170179 |
| 510k Number | K170179 |
| Device Name: | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam, IL 2069204 |
| Contact | Amaya De Levie |
| Correspondent | Amaya De Levie Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam, IL 2069204 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-19 |
| Decision Date | 2017-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143132 | K170179 | 000 |
| 07290117770061 | K170179 | 000 |
| 07290117770078 | K170179 | 000 |
| 07290117770085 | K170179 | 000 |
| 07290117770092 | K170179 | 000 |
| 07290117770108 | K170179 | 000 |
| 07290117770733 | K170179 | 000 |
| 07290117770115 | K170179 | 000 |
| 07290117770122 | K170179 | 000 |
| 07290117771037 | K170179 | 000 |
| 07290117771068 | K170179 | 000 |
| 07290117771075 | K170179 | 000 |
| 07290117771082 | K170179 | 000 |
| 07290117771044 | K170179 | 000 |
| 07290117771051 | K170179 | 000 |
| 07290109144658 | K170179 | 000 |
| 07290109141589 | K170179 | 000 |
| 07290109143125 | K170179 | 000 |
| 07290117770030 | K170179 | 000 |