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- Ophthalmic devices: recent FDA 510(k) clearances

# Ophthalmic devices: recent FDA 510(k) clearances

**7 ophthalmic devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23; the most frequent is Visco Vision, Inc. with 1. Data last updated 2026-11-04; each record links to its official source and a full report.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation

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7 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-23. Most frequent: Visco Vision, Inc. (1). Each record links to a full report and the official source.

Last updated 2026-11-04. Source: U.S. FDA openFDA.

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Records

7

Most frequent

- Visco Vision, Inc. (1)
- Heidelberg Engineering GmbH (1)
- Carl Zeiss Meditec Cataract Technologies (1)
- Bausch + Lomb, Inc. (1)
- Topcon Corporation (1)

## How do I get new ophthalmic devices: recent FDA 510(k) clearances by email?

Search, filter and export these records, or get alerts when new ones appear.

[Search and filter](/v/fdapulse?panel=Ophthalmic&record_type=clearance) [Watch this exact filter](/v/fdapulse?panel=Ophthalmic&record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing)

## What are the top ophthalmic devices: recent FDA 510(k) clearances right now?

| Record | Specialty | Type | Date |
|---|---|---|---|
| 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. | Ophthalmic | 510(k) | 2026-10-23 |
| ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH | Ophthalmic | 510(k) | 2026-09-11 |
| MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies | Ophthalmic | 510(k) | 2026-10-15 |
| Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc. | Ophthalmic | 510(k) | 2026-10-16 |
| SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation | Ophthalmic | 510(k) | 2026-09-18 |
| Miru 1day UpSide (midafilcon A) (K262495): 510(k) cleared for Menicon Co, Ltd. | Ophthalmic | 510(k) | 2026-09-17 |
| KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory | Ophthalmic | 510(k) | 2026-09-11 |

[Browse all FDAPulse record reports](/hub/fdapulse/records)

## Which related categories and locations should I check?

### Browse by record type

[510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls)

### Browse by specialty

[Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic)

### Browse by record type by specialty

[Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances)

## Frequently asked questions

### How many ophthalmic devices: recent FDA 510(k) clearances are listed?

7 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23.

### Can I get alerts for Ophthalmic devices: recent FDA 510(k) clearances?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml)

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