American Medical Optics FDA Record
American Medical Optics has 0 FDA recalls, 0 inspections, 17 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "American Medical Optics" is on file.
- Latest 510(k)
- Feb 4, 1986
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 17 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET | Feb 4, 1986 |
| K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS | May 1, 1985 |
| K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP | May 1, 1985 |
| K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA | Apr 30, 1985 |
| K844150 | MEDICAL OPTICS PHACOEMULSIFICATION KIT | Dec 11, 1984 |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | Nov 8, 1984 |
| K843965 | ARGON LASER PHOTOCOAGULATOR SYS | Nov 6, 1984 |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | Oct 1, 1984 |
| K842197 | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG | Oct 1, 1984 |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | Sep 7, 1984 |
| K842251 | AMERI. MEDICAL OPTICS ARGON LASER PHOTO | Aug 15, 1984 |
| K842250 | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE | Aug 15, 1984 |
| K842128 | AMERICAN MEDICAL OPTICS PHOTOKERATO | Aug 7, 1984 |
| K841855 | AMER. MED. OPTICS ARGON LASER PHOTO | Jun 19, 1984 |
| K841856 | AMER. MED. OPTICS ARGON/KRYPTON LASER | Jun 7, 1984 |
| K833405 | IRRIGATION ASPIRATION KIT | Jan 6, 1984 |
| K823222 | INTRAOCULAR LENS GUIDE | Dec 28, 1982 |
American Medical Optics and the FDA: common questions
Has American Medical Optics received an FDA warning letter?
No FDA warning letter addressed to the name "American Medical Optics" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has American Medical Optics received an FDA Form 483?
FDA has not published a Form 483 for "American Medical Optics" in its reading room. FDA publishes some Form 483s, not all of them.
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