AURORA HL


Device Classification Name

powered laser surgical instrument

510(k) Number K992374
Device Name AURORA HL
Applicant
PREMIER LASER SYSTEMS, INC.
#3 morgan
irvine, 
CA 
92618

Applicant Contact beth a roberts
Correspondent
PREMIER LASER SYSTEMS, INC.
#3 morgan
irvine, 
CA 
92618

Correspodent Contact beth a roberts
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 07/15/1999
Decision Date 09/22/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No