EMERGE FRACTIONAL LASER


Device Classification Name

powered laser surgical instrument with microbeamfractional output

510(k) Number K111840
Device Name EMERGE FRACTIONAL LASER
Applicant
PALOMAR MEDICAL PRODUCTS, INC.
82 cambridge st.
burlington, 
MA 
01803

Applicant Contact sharon timberlake
Correspondent
PALOMAR MEDICAL PRODUCTS, INC.
82 cambridge st.
burlington, 
MA 
01803

Correspodent Contact sharon timberlake
Regulation Number 878.4810
Classification Product Code
ONG  
Date Received 06/29/2011
Decision Date 11/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No