APOLLO MINI IPL SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K081219
Device Name APOLLO MINI IPL SYSTEM
Applicant
SANDSTONE MEDICAL TECHNOLOGIES, LLC
102 oxmoor rd.
suite 13
homewood, 
AL 
35209

Applicant Contact mark rohrer
Correspondent
SANDSTONE MEDICAL TECHNOLOGIES, LLC
102 oxmoor rd.
suite 13
homewood, 
AL 
35209

Correspodent Contact mark rohrer
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 04/30/2008
Decision Date 06/30/2008
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