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
K823767Substantially Equivalent

Erg-Jet Electrode

Life-Tech Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823767 is the FDA 510(k) clearance record for ERG-JET ELECTRODE, a class I device, cleared for Life-Tech Intl., Inc. on under FDA product code HLF (Device, Measuring, Lens Radius, Ophthalmic). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K823767.

Clearance record

Decision date
Received
(25 days to decision)
Product code
HLF Device, Measuring, Lens Radius, Ophthalmic
Regulation
21 CFR 886.1430
Device class
Class I
Review panel
Ophthalmic
Applicant
Life-Tech Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HLF

Trailing 12 months

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

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