510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940647Substantially Equivalent

Orbscan(tm) Keratometer

Orbtek, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940647 is the FDA 510(k) clearance record for ORBSCAN(TM) KERATOMETER, a class I device, cleared for Orbtek, Inc. on under FDA product code HLQ (Keratoscope, Ac-Powered). FDA records list 2 510(k) clearances for Orbtek, Inc., from to . As of , FDA records show no recalls naming K940647.

Clearance record

Decision date
Received
(141 days to decision)
Product code
HLQ Keratoscope, Ac-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Orbtek, Inc. 3030 S. Main St., Salt Lake City UT
510(k) summary
Summary
Third party review
No

Clearances, product code HLQ

Trailing 12 months

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

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