510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K960811Substantially Equivalent

Phacoscope

Saint John'S Plaza Medical Group, Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960811 is the FDA 510(k) clearance record for PHACOSCOPE, a class II device, cleared for Saint John'S Plaza Medical Group on under FDA product code HQC (Unit, Phacofragmentation). FDA records list one 510(k) clearance for Saint John'S Plaza Medical Group. As of , FDA records show no recalls naming K960811.

Clearance record

Decision date
Received
(218 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Saint John'S Plaza Medical Group 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