PETERIO UNIVERSAL LASER SCANNING HANDPIECE


Device Classification Name

powered laser surgical instrument

510(k) Number K073048
Device Name PETERIO UNIVERSAL LASER SCANNING HANDPIECE
Applicant
SCILEX, LTD.
arlozorov 41a
rishon le zion, 

IL

75214

Applicant Contact alex rapoport
Correspondent
SCILEX, LTD.
arlozorov 41a
rishon le zion, 

IL

75214

Correspodent Contact alex rapoport
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 10/29/2007
Decision Date 02/28/2008
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