Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc. (New York): 510(k) cleared for Bausch + Lomb, Inc. Its amount of 56 is below the median of 138 (13th percentile). Dated 19 days ago, it is in the active follow-up window. Score 36/100. As of 2026-11-03, 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: 56 · 13th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 6 related NY FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262941 |
| Device | Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens |
| Applicant | Bausch + Lomb, Inc. |
| Specialty / panel | Ophthalmic |
| Product code | LPL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-08-21 |
| Decision date | 2026-10-16 |
| Review time (days) | 56 |
| Third-party review | No |
| Applicant location | Rochester, NY, US |
| amount percentile | 13th of 414 (median 138, 0.4x median) |
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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: 2026-10-16
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (NY first): eClinics (K260075) · MICSI-PET (K261305) · ZBPro Diagnostic (Version 2.0) (K261580) · Class II recall Z-0204-2027 · Class II recall Z-0107-2027 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc. and 7 New York peers
- New York FDAPulse records like this one: 7
- Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc.'s amount: 13th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every New York peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 56-day review: this device is a strong predicate for similar products.
- Posted 19 days ago.
What is the FDAPulse record for Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc. in New York?
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941) by Bausch + Lomb, Inc. was cleared on 2026-10-16 after 56 days of review.
How does Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941): 510(k) cleared for Bausch + Lomb, Inc. compare to other New York FDAPulse records?
Its amount of 56 is below the median (13th percentile); smaller records often move faster and face less competition. It is 19 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens (K262941) | NY | 2026-10-16 |
| 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 |
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
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