SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER


Device Classification Name

powered laser surgical instrument

510(k) Number K080697
Device Name SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
Applicant
GLOBAL USA DISTRIBUTION, LLC.
9220 james avenue south
minneapolis, 
MN 
55431

Applicant Contact ronald berglund
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 03/12/2008
Decision Date 04/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No