510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981665Substantially Equivalent

Silon Topomat Corneal Topography Image Enhancement Device

Bio-Medical Sciences, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981665 is the FDA 510(k) clearance record for SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE, a class I device, cleared for Bio-Medical Sciences, Inc. on under FDA product code MMQ (Topographer, Corneal, Ac-Powered). FDA records list 3 510(k) clearances for Bio-Medical Sciences, Inc., from to . As of , FDA records show no recalls naming K981665.

Clearance record

Decision date
Received
(210 days to decision)
Product code
MMQ Topographer, Corneal, Ac-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Bio-Medical Sciences, Inc. 101 Technology Dr., Bethlehem PA
510(k) summary
Summary
Third party review
No

Clearances, product code MMQ

Trailing 12 months

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

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