LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR


Device Classification Name

laser, ophthalmic

510(k) Number K021538
Device Name LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
Original Applicant
LIGHTMED CORP.
no.1-1, lane1,pao-an st. sec.3
shulin city, 

TW

238

Original Contact irene lin
Regulation Number 886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received 05/10/2002
Decision Date 08/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No