LEDA

Powered Laser Surgical Instrument

QUANTEL DERMA GMBH

The following data is part of a premarket notification filed by Quantel Derma Gmbh with the FDA for Leda.

Pre-market Notification Details

• Device ID: K090762
• 510k Number: K090762
• Device Name: LEDA
• Classification: Powered Laser Surgical Instrument
• Applicant: QUANTEL DERMA GMBH AM WOLFSMANTEL 46 Erlangen, DE D-91058
• Contact: Dietmar Fischer
• Correspondent: Casey Conry; UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2009-03-23
• Decision Date: 2009-08-28
• Summary: summary