LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM


Device Classification Name

laser, ophthalmic

510(k) Number K103547
Device Name LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
Applicant
LIGHTMED CORP.
no.1-1, lane1,pao-an st. sec.3
shulin city, 

TW

238

Applicant Contact jocelyn liu
Correspondent
LIGHTMED CORP.
no.1-1, lane1,pao-an st. sec.3
shulin city, 

TW

238

Correspodent Contact jocelyn liu
Regulation Number 886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received 12/02/2010
Decision Date 11/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No