MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE

Powered Laser Surgical Instrument

MED-FIBERS, INC.

The following data is part of a premarket notification filed by Med-fibers, Inc. with the FDA for Med-fibers Surgical Laser Fiber, Med-fibers Endo-ent Laser Probes, Med-fibers End- And Aspirating Laser Probes, Med-fibe.

Pre-market Notification Details

• Device ID: K124003
• 510k Number: K124003
• Device Name: MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE
• Classification: Powered Laser Surgical Instrument
• Applicant: MED-FIBERS, INC. 2675 E. BARTLETT PLACE Chandler, AZ 85249
• Contact: Armin Kaus Phd
• Correspondent: Armin Kaus Phd; MED-FIBERS, INC. 2675 E. BARTLETT PLACE Chandler, AZ 85249
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-26
• Decision Date: 2013-01-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855950006721	K124003	000
00855950006066	K124003	000
00855950006073	K124003	000
00855950006080	K124003	000
00855950006097	K124003	000
00855950006103	K124003	000
00855950006110	K124003	000
00855950006127	K124003	000
00855950006134	K124003	000
00855950006141	K124003	000
00855950006158	K124003	000
00855950006165	K124003	000
00855950006172	K124003	000
00855950006189	K124003	000
00855950006059	K124003	000
00855950006042	K124003	000
00855950006035	K124003	000
00855950006738	K124003	000
00855950006745	K124003	000
00855950006769	K124003	000
00855950006776	K124003	000
00855950006783	K124003	000
00855950006608	K124003	000
00855950006554	K124003	000
00855950006561	K124003	000
00855950006530	K124003	000
00855950006547	K124003	000
00855950006004	K124003	000
00855950006011	K124003	000
00855950006028	K124003	000
00855950006196	K124003	000
00855950006202	K124003	000
00855950006219	K124003	000
00855950006462	K124003	000
00855950006479	K124003	000
00855950006486	K124003	000
00855950006493	K124003	000
00865325000100	K124003	000
00865325000117	K124003	000
00865325000124	K124003	000
00865325000131	K124003	000
00865325000148	K124003	000
00865325000155	K124003	000
00865325000162	K124003	000
00865325000179	K124003	000
00865325000186	K124003	000
00855950006455	K124003	000
00855950006448	K124003	000
00855950006431	K124003	000
00855950006226	K124003	000
00855950006233	K124003	000
00855950006240	K124003	000
00855950006257	K124003	000
00855950006264	K124003	000
00855950006271	K124003	000
00855950006288	K124003	000
00855950006295	K124003	000
00855950006301	K124003	000
00855950006318	K124003	000
00855950006332	K124003	000
00855950006417	K124003	000
00855950006424	K124003	000
00865325000193	K124003	000