510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964018Substantially Equivalent

Phacoilluminator - Fiberoptic Sleeve

Michael Reynard, M.D., Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964018 is the FDA 510(k) clearance record for PHACOILLUMINATOR - FIBEROPTIC SLEEVE, a class II device, cleared for Michael Reynard, M.D. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 2 510(k) clearances for Michael Reynard, M.D., from to . As of , FDA records show no recalls naming K964018.

Clearance record

Decision date
Received
(142 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Michael Reynard, M.D. 1301-20th St., #260, Santa Monica CA
510(k) summary
Summary
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260