LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS


Device Classification Name

powered laser surgical instrument

510(k) Number K121471
Device Name LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
Applicant
LIGHTSCALPEL LLC
16932 wood-red rd ne ste 201
woodinville, 
WA 
98072

Applicant Contact gerald s palecki
Correspondent
LIGHTSCALPEL LLC
16932 wood-red rd ne ste 201
woodinville, 
WA 
98072

Correspodent Contact gerald s palecki
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/18/2012
Decision Date 07/10/2012
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