Constellation Vision System
FDA 510(k) K101285 · Alcon Manufacturing, Ltd.
510(k) numberK101285
Submission
- Device name
- Constellation Vision System
- Applicant
- Alcon Manufacturing, Ltd.
Irvine, CA, US - Received
- May 7, 2010
- Decision date
- November 12, 2010
- 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 Constellation Vision System cleared by the FDA?
Constellation Vision System (K101285) received a 510(k) decision of Substantially Equivalent on November 12, 2010, 189 days after the submission was received.
What is the product code of K101285?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.