K-number	K242801
Device name	MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
Applicant	Carl Zeiss Meditec Cataract Technology, Inc.
Product code	HQC
Device class	Class II
Decision date	Jun 11, 2025
Decision	Substantially Equivalent
Regulation	886.4670

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The MICOR 700 System is a phacofragmentation device designed for fragmentation and removal of cataracts. It performs associated procedures such as irrigation and aspiration, as well as ancillary functions including vitreous aspiration and cutting. The system consists of a drive unit (FG-50631), extractor (FG-50621), and vitrector (FG-51185) and is intended for prescription use.

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 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

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