One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series— 510(k) K143434
Substantially EquivalentAbbott Medical Optics, Inc.
FDA 510(k) clearance K143434 for One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series, Substantially Equivalent on 2015-05-06. Applicant: Abbott Medical Optics, Inc.. Device class: 1.
Clearance details
- Applicant
- Abbott Medical Optics, Inc.
- Product code
- Code MSS
- Device class
- Class 1
- Regulation
- 21 CFR 886.4300
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Santa Ana, CA, US
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Adverse events under product code MSS
product code MSS- Injury
- 385
- Malfunction
- 2,033
- Total
- 2,418
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.