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 |