510(k) clearance

MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)

FDA 510(k) source

510(k) number

K262097

Applicant

Carl Zeiss Meditec Cataract Technologies

Decision date

Oct 15, 2026

Date received

Jun 22, 2026

Decision

Substantially Equivalent

Clearance type

Special

Product code

HQC

Device type

Unit, Phacofragmentation

Device class

Class II

Regulation

21 CFR 886.4670

Advisory committee

Ophthalmic

Statement or summary

Summary

Third party

N

Location

Reno, NV, US