Where does the data come from?

U.S. FDA openFDA (510(k) clearances and device enforcement reports). Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252723

Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.

Q: How to monitor Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. and peer general & plastic surgery records

FDAPulse lists new FDAPulse records from U.S. FDA openFDA (510(k) clearances and device enforcement reports) as they are published; a free weekly email digest and paid alerts follow records like this one.

Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.: 510(k) cleared for Fotona D.O.O. Its amount of 387 is top-decile (99th percentile of 414 records). Dated 47 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 2026-11-04 · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

amount: 387 · 99th percentile of 414 FDAPulse records · 2.8x the median

Free preview: all 14 published fields of this record are shown below. Locked: 0 related SI FDAPulse records and the 5-column CSV export.

Field	Value
Record	510(k) clearance
510(k) number	K252723
Device	Dynamis Pro Family
Applicant	Fotona D.O.O.
Specialty / panel	General, Plastic Surgery
Product code	GEX
Device class	2
Clearance type	Traditional
Decision	Substantially Equivalent
Received	2025-08-28
Decision date	2026-09-19
Review time (days)	387
Third-party review	No
Applicant location	Ljubljana, SI
amount percentile	99th of 414 (median 138, 2.8x median)
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Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Record date: 2026-09-19
Data refreshed: 2026-11-04
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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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55 / 100 Predicate Speed & CAPA Advisory Opportunity Score

A long 387-day review suggests additional-information requests: a firm likely to value regulatory help next time.

What is the FDAPulse record for Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O.?

Dynamis Pro Family (K252723) by Fotona D.O.O. was cleared on 2026-09-19 after 387 days of review.

How does Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. compare to other FDAPulse records?

This is a top-decile record: its amount of 387 is 2.8x the median of 138 across 414 records. It is 47 days old; check the official source for later updates before acting.

Dynamis Pro Family (K252723) vs. top 3 peers

Organization	Location	Record date	Compare
Dynamis Pro Family (K252723)	SI	2026-09-19	This record
TECAR Therapy Device (TC2000, TC2001) (K252288)	CN	2026-10-13	Compare Dynamis Pro Family (K252723) vs TECAR Therapy Device (TC2000, TC2001) (K252288) →
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	View record →
PicoreMax (PicoreMax) (K254199)	KR	2026-09-24	View record →

Compare Dynamis Pro Family (K252723) vs VacHeal Negative Pressure Wound Therapy System (K254160) →

How to monitor Dynamis Pro Family (K252723): 510(k) cleared for Fotona D.O.O. and peer general & plastic surgery records

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