# MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies

**Predicate Speed & CAPA Advisory Opportunity Score:** 41/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262097 |
| Device | MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) |
| Applicant | Carl Zeiss Meditec Cataract Technologies |
| Specialty / panel | Ophthalmic |
| Product code | HQC |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-06-22 |
| Decision date | 2026-10-15 |
| Review time (days) | 115 |
| Third-party review | No |
| Applicant location | Reno, NV, US |

## Why this score
- Fast 115-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 21 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262097). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.