SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES


Device Classification Name

powered laser surgical instrument

510(k) Number K080248
Device Name SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
Applicant
LUTRONIC CORPORATION
5 timber lane
north reading, 
MA 
01864

Applicant Contact maureen o’connell
Correspondent
LUTRONIC CORPORATION
5 timber lane
north reading, 
MA 
01864

Correspodent Contact maureen o’connell
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 01/31/2008
Decision Date 04/23/2008
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