510(k) K031960 ยท GEX Powered Laser Surgical Instrument
INTRALASE FS LASER
| Applicant | Intra Lase Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 29, 2003 |
| Received | Jun 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031960
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Pr Terminated |
HNO | None listed |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Product Usage: Terminated |
HNO | None listed |
| Nov 4, 2011 | AMO Manufacturing USA, LLC Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K;
Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
Product Usage: Intended Terminated |
HNO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.