TXCELL SCANNING LASER DELIVERY SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K121475
Device Name TXCELL SCANNING LASER DELIVERY SYSTEM
Applicant
IRIDEX CORP.
1212 terra bella ave
mountain view, 
CA 
94043

Applicant Contact paul h hardiman
Correspondent
IRIDEX CORP.
1212 terra bella ave
mountain view, 
CA 
94043

Correspodent Contact paul h hardiman
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 05/18/2012
Decision Date 11/28/2012
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