510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880855Substantially Equivalent

Parel Rare Earth Magnet, I.o.m., Intraocular Mag

Richard James, Inc., Lynnfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880855 is the FDA 510(k) clearance record for PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG, a class I device, cleared for Richard James, Inc. on under FDA product code HPN (Magnet, Permanent). FDA records list 2 510(k) clearances for Richard James, Inc., from to . As of , FDA records show no recalls naming K880855.

Clearance record

Decision date
Received
(31 days to decision)
Product code
HPN Magnet, Permanent
Regulation
21 CFR 886.4445
Device class
Class I
Review panel
Ophthalmic
Applicant
Richard James, Inc. P.O. Box 309, Lynnfield MA
Third party review
No

Clearances, product code HPN

Trailing 12 months

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

FDA records show no clearances under product code HPN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HPN, 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