Darwin

Powered Laser Surgical Instrument

Luvo Medical Technologies, Inc

The following data is part of a premarket notification filed by Luvo Medical Technologies, Inc with the FDA for Darwin.

Pre-market Notification Details

• Device ID: K203728
• 510k Number: K203728
• Device Name: Darwin
• Classification: Powered Laser Surgical Instrument
• Applicant: Luvo Medical Technologies, Inc 125 Fleming Drive Cambridge, CA N1t 2b8
• Contact: Gregory Berzak
• Correspondent: Gregory Berzak; Luvo Medical Technologies, Inc 125 Fleming Drive Cambridge, CA N1t 2b8
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-21
• Decision Date: 2021-07-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00754016214172	K203728	000
00754016214165	K203728	000
00754016214158	K203728	000
00754016214134	K203728	000