PHOTON PHOTON PLUS


Device Classification Name

powered laser surgical instrument

510(k) Number K122020
Device Name PHOTON PHOTON PLUS
Applicant
ZOLAR TECHNOLOGY & MFG. CO. INC.
55 northern blvd
suite 200
great neck, 
NY 
11021

Applicant Contact susan d goldstein-falk
Correspondent
ZOLAR TECHNOLOGY & MFG. CO. INC.
55 northern blvd
suite 200
great neck, 
NY 
11021

Correspodent Contact susan d goldstein-falk
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/10/2012
Decision Date 06/05/2013
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