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# KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory vs MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies: FDAPulse comparison

**KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory's review days of 148 is 1.3x MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies's 115 (55th percentile). KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory is dated 2026-09-11; MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies 2026-10-15.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA (510(k) clearances and device enforcement reports) Copy citation

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## How does KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory compare to MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies?

| Field | KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory | MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K261255 | K262097 |
| Device | KOWA FM-600 | MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) |
| Applicant | Kowa Company, Ltd. Chofu Factory | Carl Zeiss Meditec Cataract Technologies |
| Specialty / panel | Ophthalmic | Ophthalmic |
| Product code | MYC | HQC |
| Device class | 2 | 2 |
| Clearance type | Traditional | Special |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2026-04-16 | 2026-06-22 |
| Decision date | 2026-09-11 | 2026-10-15 |
| Review time (days) | 148 | 115 |
| Third-party review | No | No |
| Applicant location | Tokyo, JP | Reno, NV, US |
| amount percentile | 55th | 42nd |
| Predicate Speed & CAPA Advisory Opportunity Score | 30/100 | 41/100 |
| Peer rank and all 500 records (CSV) | Every comparable record ranked, with amounts, dates and scores 🔒 Click to unlock → |
| Official source URLs for every peer record | Direct links to each record at its government source 🔒 Click to unlock → |

Official records: [KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261255) · [MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262097)

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