510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781543Substantially Equivalent

Orbiograph

Sonometrics Systems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781543 is the FDA 510(k) clearance record for ORBIOGRAPH, a class II device, cleared for Sonometrics Systems, Inc. on under FDA product code HLT (Preamplifier, Ac-Powered, Ophthalmic). FDA records list 4 510(k) clearances for Sonometrics Systems, Inc., from to . As of , FDA records show no recalls naming K781543.

Clearance record

Decision date
Received
(46 days to decision)
Product code
HLT Preamplifier, Ac-Powered, Ophthalmic
Regulation
21 CFR 886.1640
Device class
Class II
Review panel
Ophthalmic
Applicant
Sonometrics Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HLT

Trailing 12 months

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

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