StarWalker

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 Starwalker.

Pre-market Notification Details

• Device ID: K171227
• 510k Number: K171227
• Device Name: StarWalker
• Classification: Powered Laser Surgical Instrument
• Applicant: Fotona D.o.o. Stegne 7 Ljubljana, SI 1000
• Contact: Stojan Trost
• Correspondent: Stojan Trost; Fotona D.o.o. Stegne 7 Ljubljana, 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: 2017-04-26
• Decision Date: 2017-08-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03830054230354	K171227	000
03830054230330	K171227	000