WATERLASE


Device Classification Name

powered laser surgical instrument

510(k) Number K030523
Device Name WATERLASE
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 02/19/2003
Decision Date 01/30/2004
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