MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies
MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies (Nevada): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies. Its amount of 115 is below the median of 138 (42nd percentile). Dated 21 days ago, it is in the active follow-up window. Score 41/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 115 · 42th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 1 related NV FDAPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 42th of 414 (median 138, 0.8x median) |
| Peer records CSV (2 NV records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-15
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies and 2 Nevada peers
- Nevada FDAPulse records like this one: 2
- MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies's amount: 42nd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Nevada peer: $400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity 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.
What is the FDAPulse record for MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies in Nevada?
MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) by Carl Zeiss Meditec Cataract Technologies was cleared on 2026-10-15 after 115 days of review.
How does MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies compare to other Nevada FDAPulse records?
Its amount of 115 is below the median (42th percentile); smaller records often move faster and face less competition. It is 21 days old, still within a typical 45-day follow-up window.
MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) vs. top 3 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) | NV | 2026-10-15 | This record |
| OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens (K253875) | TW | 2026-10-23 | View record → |
| ANTERION (K261019) | DE | 2026-09-11 | Compare MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) vs ANTERION (K261019) → |
| Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941) | NY | 2026-10-16 | View record → |
Compare MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) vs KOWA FM-600 (K261255) →
Related records
- OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens (K253875): 510(k) cleared for Visco Vision, Inc.
- ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH
- Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.
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