SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation
SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation: LED) (K262637): 510(k) cleared for Topcon Corporation. Its amount of 51 is below the median of 138 (12th percentile). Dated 47 days ago, it serves as a historical benchmark. Score 30/100. 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: 51 · 12th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 9 related JP FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262637 |
| Device | SLIT LAMP SL-D4 (Type: LED) |
| Applicant | Topcon Corporation |
| Specialty / panel | Ophthalmic |
| Product code | HJO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-29 |
| Decision date | 2026-09-18 |
| Review time (days) | 51 |
| Third-party review | No |
| Applicant location | Tokyo, JP |
| amount percentile | 12th 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: 2026-09-18
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (JP first): Lilium one (USM330) (K260605) · SCENARIA View Phase 6.0 (K261229) · APERTO Lucent MRI System (K261283) · KOWA FM-600 (K261255) · DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece ( · 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: SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation and 10 JP peers
- JP FDAPulse records like this one: 10
- SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation's amount: 12th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 51-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation?
SLIT LAMP SL-D4 (Type: LED) (K262637) by Topcon Corporation was cleared on 2026-09-18 after 51 days of review.
How does SLIT LAMP SL-D4 (Type: LED) (K262637): 510(k) cleared for Topcon Corporation compare to other FDAPulse records?
Its amount of 51 is below the median (12th percentile); smaller records often move faster and face less competition. It is 47 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
SLIT LAMP SL-D4 (Type vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| SLIT LAMP SL-D4 (Type | JP | 2026-09-18 |
| Miru 1day UpSide (midafilcon A) (K262495) | JP | 2026-09-17 |
| KOWA FM-600 (K261255) | JP | 2026-09-11 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Ophthalmic devices
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