ACCENT

Electrosurgical, Cutting & Coagulation & Accessories

ALMA LASERS LTD.

The following data is part of a premarket notification filed by Alma Lasers Ltd. with the FDA for Accent.

Pre-market Notification Details

• Device ID: K070004
• 510k Number: K070004
• Device Name: ACCENT
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566
• Contact: Anne Worden
• Correspondent: Anne Worden; ALMA LASERS LTD. 3637 BERNAL AVE. Pleasanton, CA 94566
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-03
• Decision Date: 2007-04-23
• Summary: summary