510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170655Substantially Equivalent

Zepto

Mynosys Cellular Devices, Inc., Fremont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170655 is the FDA 510(k) clearance record for Zepto, a class II device, cleared for Mynosys Cellular Devices, Inc. on under FDA product code PUL (Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered). FDA's definition for product code PUL reads: "Used to perform anterior capsulotomy during cataract surgery". FDA records list one 510(k) clearance for Mynosys Cellular Devices, Inc. As of , FDA records show no recalls naming K170655.

Clearance record

Decision date
Received
(91 days to decision)
Product code
PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Regulation
21 CFR 886.4100
Device class
Class II
Review panel
Ophthalmic
Applicant
Mynosys Cellular Devices, Inc. 46710 Fremont Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PUL

Trailing 12 months

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

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