Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC (Florida): 510(k) cleared for Bh Group Us, LLC. Its amount of 715 is top-decile (99th percentile of 414 records). Dated 43 days ago, it serves as a historical benchmark. Score 61/100. 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: 715 · 99th percentile of 414 FDAPulse records · 5.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K243223 |
| Device | Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) |
| Applicant | Bh Group Us, LLC |
| Specialty / panel | General, Plastic Surgery |
| Product code | PBX |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2024-10-07 |
| Decision date | 2026-09-22 |
| Review time (days) | 715 |
| Third-party review | No |
| Applicant location | Davie, FL, US |
| amount percentile | 99th of 414 (median 138, 5.2x 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: 2026-09-22
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (FL first): Hemotag Analysis Software (HAS) (K252736) · Durashield Device Kit (K252995) · epi-ConneKt Wound Matrix (K260530) · BellaTek Bars (K260940) · Yomi S Robotic System (K261321) · 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: Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC and 16 Florida peers
- Florida FDAPulse records like this one: 16
- Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC's amount: 99th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 715-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 43 days ago.
What is the FDAPulse record for Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC in Florida?
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223) by Bh Group Us, LLC was cleared on 2026-09-22 after 715 days of review.
How does Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223): 510(k) cleared for Bh Group Us, LLC compare to other Florida FDAPulse records?
This is a top-decile record: its amount of 715 is 5.2x the median of 138 across 414 records. It is 43 days old, still within a typical 45-day follow-up window.
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) (K243223) | FL | 2026-09-22 |
| 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 |
Related records
- TECAR Therapy Device (TC2000, TC2001) (K252288): 510(k) cleared for Shenzhen Dongdixin Technology Co., Ltd.
- 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): 510(k) cleared for Ezisurg Medical Co., Ltd.
- PicoreMax (PicoreMax) (K254199): 510(k) cleared for BLUECORE COMPANY Co., Ltd.
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