Mini Me

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.)

The following data is part of a premarket notification filed by Iluminage Ltd.(formerly Syneron Beauty Ltd.) with the FDA for Mini Me.

Pre-market Notification Details

• Device ID: K143339
• 510k Number: K143339
• Device Name: Mini Me
• Classification: Powered Light Based Non-laser Surgical Instrument With Thermal Effect
• Applicant: ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) KOCHAV YOKNEAM BLDG. YOKNEAM INDUSTRIAL ZONE Yokneam Illit, IL 20692
• Contact: Bobae Kim
• Correspondent: Janice M Hogan; HOGAN LOVELLS US LLP 1835 MARKET ST., 29TH FL Philadelphia, PA 19103
• Product Code: ONF
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-20
• Decision Date: 2014-12-19
• Summary: summary