Catalys Precision Laser System— 510(k) K170322
Substantially EquivalentAbbott Medical Optics, Inc.
FDA 510(k) clearance K170322 for Catalys Precision Laser System, Substantially Equivalent on 2017-05-19. Applicant: Abbott Medical Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Abbott Medical Optics, Inc.
- Product code
- Code OOE
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milpitas, CA, US
Recent devices under product code OOE
view allMore clearances from Abbott Medical Optics, Inc.
view all- K160236 — Dual Pump Pack
- K151636 — AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
- K151783 — COMPACT INTUITIV Multiple-Use Pack
- K143434 — One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
- K133115 — COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
Adverse events under product code OOE
product code OOE- Injury
- 1,104
- Malfunction
- 864
- Total
- 1,968
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 →
Recalls naming K170322
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170322.
Data sourced from openFDA. This site is unofficial and independent of the FDA.