Company ยท US
American Optisurgical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2010. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2010 | K101561 | TX1 TISSUE REMOVAL SYSTEM American Optisurgical, Inc. | LFL |
| Sep 22, 2008 | K080803 | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 American Optisurgical, Inc. | HQC |
| Jul 9, 2002 | K020527 | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030 American Optisurgical, Inc. | HQC |
| Dec 26, 1995 | K953539 | DM001 DISPOSABLE PACK American Optisurgical, Inc. | HQC |
| Dec 26, 1995 | K953538 | RM001 REUSABLE American Optisurgical, Inc. | HQC |
| Aug 16, 1995 | K952331 | AOI LC-40 PHACOEMULSIFIER American Optisurgical, Inc. | HQC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2013 | American Optisurgical Inc TX1 Tissue Removal System Console. Model: TX1
TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation Terminated |
LFL | K101561 |
| Jun 7, 2013 | American Optisurgical Inc TX1 Tissue Removal System disposable handpieces.
Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft t Terminated |
LFL | None listed |
| Jun 6, 2013 | American Optisurgical Inc American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. Terminated |
LFL | K101561 |
| Jun 6, 2013 | American Optisurgical Inc FAST Procedure Kit.
Intended for use as a Minor Surgical Procedures Tray. Terminated |
OJU | None listed |
| Sep 4, 2009 | American Optisurgical Inc American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. Terminated |
HQC | K020527 |