510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952597Substantially Equivalent

View Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun Pockets, Point of View

Point of View Optical Outlet, Inc., Aventura FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952597 is the FDA 510(k) clearance record for VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW, a class I device, cleared for Point of View Optical Outlet, Inc. on under FDA product code HQZ (Frame, Spectacle). FDA records list one 510(k) clearance for Point of View Optical Outlet, Inc. As of , FDA records show no recalls naming K952597.

Clearance record

Decision date
Received
(98 days to decision)
Product code
HQZ Frame, Spectacle
Regulation
21 CFR 886.5842
Device class
Class I
Review panel
Ophthalmic
Applicant
Point of View Optical Outlet, Inc. 18757 Biscayne Blvd., Aventura FL
510(k) summary
Statement
Third party review
No

Clearances, product code HQZ

Trailing 12 months

FDA records hold no clearances under product code HQZ in the trailing twelve months.

FDA records show no clearances under product code HQZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260