EMERGE FRACTIONAL LASER

Powered Laser Surgical Instrument With Microbeam\fractional Output

PALOMAR MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Palomar Medical Products, Inc. with the FDA for Emerge Fractional Laser.

Pre-market Notification Details

• Device ID: K111840
• 510k Number: K111840
• Device Name: EMERGE FRACTIONAL LASER
• Classification: Powered Laser Surgical Instrument With Microbeam\fractional Output
• Applicant: PALOMAR MEDICAL PRODUCTS, INC. 82 CAMBRIDGE ST. Burlington, MA 01803
• Contact: Sharon Timberlake
• Correspondent: Sharon Timberlake; PALOMAR MEDICAL PRODUCTS, INC. 82 CAMBRIDGE ST. Burlington, MA 01803
• Product Code: ONG
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-29
• Decision Date: 2011-11-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841494100643	K111840	000
00841494100629	K111840	000
00841494100186	K111840	000
00841494100179	K111840	000