SkyPulse

Powered Laser Surgical Instrument

Fotona D.o.o.

The following data is part of a premarket notification filed by Fotona D.o.o. with the FDA for Skypulse.

Pre-market Notification Details

• Device ID: K193656
• 510k Number: K193656
• Device Name: SkyPulse
• Classification: Powered Laser Surgical Instrument
• Applicant: Fotona D.o.o. Stegne 7 Ljubljana, SI Si-1000
• Contact: Marko Berdajs
• Correspondent: Marko Berdajs; Fotona D.o.o. Stegne 7 Ljubljana, SI Si-1000
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-30
• Decision Date: 2020-03-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03830054230408	K193656	000
03830054230392	K193656	000