CANDELA GENTLEMAX FAMILY OF LASER SYSTEM

Powered Laser Surgical Instrument

CANDELA CORP.

The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Gentlemax Family Of Laser System.

Pre-market Notification Details

• Device ID: K140122
• 510k Number: K140122
• Device Name: CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
• Classification: Powered Laser Surgical Instrument
• Applicant: CANDELA CORP. 530 BOSTON POST ROAD Wayland, MA 01778
• Contact: Sam Wade
• Correspondent: Sam Wade; CANDELA CORP. 530 BOSTON POST ROAD Wayland, MA 01778
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-16
• Decision Date: 2014-05-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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