Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list American Optisurgical with 6 510(k) clearances and 4 device recalls. The most recent is a device recall dated Apr 30, 2013: TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Remov….
| Apr 30, 2013 | TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedureClass II · American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory | Device recalls |
| Apr 30, 2013 | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.Class II · American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall | Device recalls |
| Mar 30, 2013 | American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.Class II · The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection cir | Device recalls |
| Feb 22, 2012 | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue.Class II · Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a | Device recalls |
| Aug 27, 2010 | TX1 TISSUE REMOVAL SYSTEMK101561 · LFL | 510(k) clearances |
| Sep 22, 2008 | VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551K080803 · HQC | 510(k) clearances |
| Jul 9, 2002 | HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030K020527 · HQC | 510(k) clearances |
| Dec 26, 1995 | DM001 DISPOSABLE PACKK953539 · HQC | 510(k) clearances |
| Dec 26, 1995 | RM001 REUSABLEK953538 · HQC | 510(k) clearances |
| Aug 16, 1995 | AOI LC-40 PHACOEMULSIFIERK952331 · HQC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
