LASERSMILE


Device Classification Name

powered laser surgical instrument

510(k) Number K030539
Device Name LASERSMILE
Applicant
BIOLASE TECHNOLOGY, INC.
981 calle amanecer
san clemente, 
CA 
92673

Applicant Contact ioana m rizoiu
Correspondent
BIOLASE TECHNOLOGY, INC.
981 calle amanecer
san clemente, 
CA 
92673

Correspodent Contact ioana m rizoiu
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/20/2003
Decision Date 10/10/2003
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