510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053622Substantially Equivalent

Surgisis Ocular Graft

Iop, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053622 is the FDA 510(k) clearance record for SURGISIS OCULAR GRAFT, a class II device, cleared for Iop, Inc. on under FDA product code NXM (Prosthesis, Eyelid Spacer/Graft, Biologic). FDA's definition for product code NXM reads: "For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid". FDA records list 7 510(k) clearances for Iop, Inc., from to . As of , FDA records show no recalls naming K053622.

Clearance record

Decision date
Received
(77 days to decision)
Product code
NXM Prosthesis, Eyelid Spacer/Graft, Biologic
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Applicant
Iop, Inc. 3184 Airway Ave., Bldg. B, Costa Mesa CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NXM

Trailing 12 months

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

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