510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010852Substantially Equivalent

Osmed Tissue Expander

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

K010852 is the FDA 510(k) clearance record for OSMED TISSUE EXPANDER, a class II device, cleared for Iop, Inc. on under FDA product code NFM (Expander, Tissue, Orbital). FDA records list 7 510(k) clearances for Iop, Inc., from to . As of , FDA records show no recalls naming K010852.

Clearance record

Decision date
Received
(145 days to decision)
Product code
NFM Expander, Tissue, Orbital
Regulation
21 CFR 886.3320
Device class
Class II
Review panel
Ophthalmic
Applicant
Iop, Inc. 3151 Airway Ave., Bldg. I-1, Costa Mesa CA
510(k) summary
Statement
Third party review
No

Clearances, product code NFM

Trailing 12 months

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

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