510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963762Substantially Equivalent

Corneal Topographer 200

Eclipse Ventures, Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963762 is the FDA 510(k) clearance record for CORNEAL TOPOGRAPHER 200, a class I device, cleared for Eclipse Ventures on under FDA product code MMQ (Topographer, Corneal, Ac-Powered). FDA records list one 510(k) clearance for Eclipse Ventures. As of , FDA records show no recalls naming K963762.

Clearance record

Decision date
Received
(95 days to decision)
Product code
MMQ Topographer, Corneal, Ac-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Eclipse Ventures 108 Sayre Dr., Princeton NJ
510(k) summary
Statement
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