K-number	K243395
Device name	MICOR 700 with Auto I/A
Applicant	Carl Zeiss Meditec Cataract Technology, Inc.
Product code	HQC
Device class	Class II
Decision date	Aug 8, 2025
Decision	Substantially Equivalent
Regulation	886.4670

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The MICOR 700 with Auto I/A is a phacofragmentation system for cataract surgery that fragments and removes cataracts through phacoemulsification. It also performs associated procedures including irrigation and aspiration, and ancillary functions such as vitreous aspiration and cutting.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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MICOR 700 with Auto I/A

Everything you need for a 510(k) submission. Nothing you don't.