20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25


Device Classification Name

powered laser surgical instrument

510(k) Number K021696
Device Name 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
Original Applicant
OPHTHALMED LLC
1308 morningside park dr.
alpharetta, 
GA 
30022

Original Contact jay mansour
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/22/2002
Decision Date 08/20/2002
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