20G SMA LASER FIBER, MODEL LF100


Device Classification Name

laser, ophthalmic

510(k) Number K050807
Device Name 20G SMA LASER FIBER, MODEL LF100
Applicant
OPHTHALMED LLC
1308 morningside park dr.
alpharetta, 
GA 
30022

Applicant Contact jay mansour
Correspondent
OPHTHALMED LLC
1308 morningside park dr.
alpharetta, 
GA 
30022

Correspodent Contact jay mansour
Regulation Number 886.4390
Classification Product Code
HQF  
Date Received 03/30/2005
Decision Date 09/21/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No