SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd.
SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd. (Illinois): 510(k) cleared for Lumenis Be, Ltd. Its amount of 806 is top-decile (99th percentile of 414 records). Dated 46 days ago, it serves as a historical benchmark. Score 55/100. 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: 806 · 99th percentile of 414 FDAPulse records · 5.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 56 related IL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K241973 |
| Device | SmartIPL_NI System |
| Applicant | Lumenis Be, Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | GEX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2024-07-05 |
| Decision date | 2026-09-19 |
| Review time (days) | 806 |
| Third-party review | No |
| Applicant location | Yokneam Ilit, IL |
| amount percentile | 99th of 414 (median 138, 5.8x 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: 2026-09-19
- 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: SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd. and 57 Illinois peers
- Illinois FDAPulse records like this one: 57
- SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd.'s amount: 99th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Illinois peer: $11,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 806-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd. in Illinois?
SmartIPL_NI System (K241973) by Lumenis Be, Ltd. was cleared on 2026-09-19 after 806 days of review.
How does SmartIPL_NI System (K241973): 510(k) cleared for Lumenis Be, Ltd. compare to other Illinois FDAPulse records?
This is a top-decile record: its amount of 806 is 5.8x the median of 138 across 414 records. It is 46 days old; check the official source for later updates before acting.
SmartIPL_NI System (K241973) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| SmartIPL_NI System (K241973) | IL | 2026-09-19 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
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- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
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