Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack
FDA 510(k) K133115 · Abbott Medical Optics, Inc.
510(k) numberK133115
Submission
- Device name
- Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack
- Applicant
- Abbott Medical Optics, Inc.
Santa Ana, CA, US - Received
- September 30, 2013
- Decision date
- February 27, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack cleared by the FDA?
Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use Fluidics Pack (K133115) received a 510(k) decision of Substantially Equivalent on February 27, 2014, 150 days after the submission was received.
What is the product code of K133115?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.