Iris Retracting Phacoemulsification Sleeve
FDA 510(k) K002812 · Michael Reynard, M.D.
510(k) numberK002812
Submission
- Device name
- Iris Retracting Phacoemulsification Sleeve
- Applicant
- Michael Reynard, M.D.
Santa Monica, CA, US - Received
- September 8, 2000
- Decision date
- November 8, 2000
- 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 Iris Retracting Phacoemulsification Sleeve cleared by the FDA?
Iris Retracting Phacoemulsification Sleeve (K002812) received a 510(k) decision of Substantially Equivalent on November 8, 2000, 61 days after the submission was received.
What is the product code of K002812?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.