The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Acupulse (previously Called Acupulse 30/40 St); Acupulse 40w G; Acupulse Duo.
| Device ID | K180597 |
| 510k Number | K180597 |
| Device Name: | AcuPulse (previously Called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Lumenis Ltd. 6 Hakidma Street P O Box 240 Yokneam, IL 2069204 |
| Contact | Amaya De Levie |
| Correspondent | Amaya De Levie Lumenis Ltd. 6 Hakidma Street P O Box 240 Yokneam, IL 2069204 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-06 |
| Decision Date | 2018-04-03 |
| Summary: | summary |