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.
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.: 510(k) cleared for Visco Vision, Inc. Its amount of 323 is top-decile (97th percentile of 414 records). Dated 12 days ago, it is in the active follow-up window. Score 67/100. 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: 323 · 97th percentile of 414 FDAPulse records · 2.3x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related TW FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253875 |
| Device | 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 |
| Applicant | Visco Vision, Inc. |
| Specialty / panel | Ophthalmic |
| Product code | LPL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-04 |
| Decision date | 2026-10-23 |
| Review time (days) | 323 |
| Third-party review | No |
| Applicant location | Taoyuan City, TW |
| amount percentile | 97th of 414 (median 138, 2.3x median) |
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Watch 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.
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-23
- Data refreshed: 2026-11-04
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Top FDAPulse records (TW first): Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Trac · OOOPDS (K254214) · EASYMAX Voice Blood Glucose Monitoring System (K261293) · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Browse all by state and category →
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: 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. and 4 TW peers
- TW FDAPulse records like this one: 4
- 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.'s amount: 97th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every TW peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
67 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 323-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 12 days ago.
What is the FDAPulse record for 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.?
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) by Visco Vision, Inc. was cleared on 2026-10-23 after 323 days of review.
How does 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. compare to other FDAPulse records?
This is a top-decile record: its amount of 323 is 2.3x the median of 138 across 414 records. It is fresh: dated 12 days ago, inside the window where early outreach matters most.
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) vs. top 3 peers
| Organization | Location | Record 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) | TW | 2026-10-23 |
| ANTERION (K261019) | DE | 2026-09-11 |
| MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097) | NV | 2026-10-15 |
| Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941) | NY | 2026-10-16 |
Related records
- ANTERION (K261019): 510(k) cleared for Heidelberg Engineering GmbH
- MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies
- Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.
- SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation
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- Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230): 510(k) cleared for Suzhou Medical Appliance Factory
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Ophthalmic devices
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