Phacoilluminator - Fiberoptic Sleeve
FDA 510(k) K964018 · Michael Reynard, M.D.
510(k) numberK964018
Submission
- Device name
- Phacoilluminator - Fiberoptic Sleeve
- Applicant
- Michael Reynard, M.D.
Santa Monica, CA, US - Received
- October 7, 1996
- Decision date
- February 26, 1997
- 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 Phacoilluminator - Fiberoptic Sleeve cleared by the FDA?
Phacoilluminator - Fiberoptic Sleeve (K964018) received a 510(k) decision of Substantially Equivalent on February 26, 1997, 142 days after the submission was received.
What is the product code of K964018?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.