SMARTLUX

Powered Laser Surgical Instrument

MEDMIX CO., LTD

The following data is part of a premarket notification filed by Medmix Co., Ltd with the FDA for Smartlux.

Pre-market Notification Details

• Device ID: K120460
• 510k Number: K120460
• Device Name: SMARTLUX
• Classification: Powered Laser Surgical Instrument
• Applicant: MEDMIX CO., LTD 300 ATWOOD Pittsburgh, PA 15213
• Contact: Peter Chung
• Correspondent: Peter Chung; MEDMIX CO., LTD 300 ATWOOD Pittsburgh, PA 15213
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-15
• Decision Date: 2012-10-01
• Summary: summary