510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050768Substantially Equivalent

Zilos-Tk, Version 3, Zilos-Tk, Version 4

Hamilton Thorne Biosciences, Beverly MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K050768 is the FDA 510(k) clearance record for ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4, a class II device, cleared for Hamilton Thorne Biosciences on under FDA product code MRX (System, Assisted Reproduction Laser). FDA's definition for product code MRX reads: "This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced...". FDA records list 3 510(k) clearances for Hamilton Thorne Biosciences, from to . As of , FDA records show no recalls naming K050768.

Clearance record

Decision date
Received
(34 days to decision)
Product code
MRX System, Assisted Reproduction Laser
Regulation
21 CFR 884.6200
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hamilton Thorne Biosciences 181 Elliott St., Beverly MA
510(k) summary
Statement
Third party review
No

Clearances, product code MRX

Trailing 12 months
1 clearance under product code MRX in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MRX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260