Sovereign Compact Phacoemulsification System
FDA 510(k) K111446 · Abbott Medical Optics, Inc.
510(k) numberK111446
Submission
- Device name
- Sovereign Compact Phacoemulsification System
- Applicant
- Abbott Medical Optics, Inc.
Santa Ana, CA, US - Received
- May 24, 2011
- Decision date
- December 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Sovereign Compact Phacoemulsification System cleared by the FDA?
Sovereign Compact Phacoemulsification System (K111446) received a 510(k) decision of Substantially Equivalent on December 21, 2011, 211 days after the submission was received.
What is the product code of K111446?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.