ADVANTAGE

Powered Laser Surgical Instrument

LUTRONIC CORPORATION

The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for Advantage.

Pre-market Notification Details

• Device ID: K141555
• 510k Number: K141555
• Device Name: ADVANTAGE
• Classification: Powered Laser Surgical Instrument
• Applicant: LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 100 Trevose, PA 19053
• Contact: Jhung W Vojir
• Correspondent: Jhung W Vojir; LUTRONIC CORPORATION 6 NESHAMINY INTERPLEX, SUITE 100 Trevose, PA 19053
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-06-12
• Decision Date: 2014-11-06
• Summary: summary