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
K210827Substantially Equivalent

ZEPTO Precision Capsulotomy System

Centricity Vision, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210827 is the FDA 510(k) clearance record for ZEPTO Precision Capsulotomy System, a class II device, cleared for Centricity Vision, 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 3 510(k) clearances for Centricity Vision, Inc., from to . As of , FDA records show no recalls naming K210827.

Clearance record

Decision date
Received
(270 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
Centricity Vision, Inc. 1939 Palomar Oaks Way, Suite A, Carlsbad 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