510(k) · Cleared
ClearedSpecchio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En S.P.A. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Apr 2, 2026 as substantially equivalent to K211091 (El.En Electronic Engineering Spa, 2021) after a 34-day review. Its family tree reaches back 5 generations to 2012.
- Decided
- Apr 2, 2026
- Review
- 34 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K122389 (2012). No later device cites it as a predicate yet.
- Root · 5 generations backK122389 TrusculptCutera, Inc. · 2012 · Recalled
- 4 generations backK132949 PellefirmEllman International, Inc. · 2014
- 3 generations backK143040 Exilis XPBTL Industries, Inc. · 2015
- 2 generations backK183371 Deka Tiac 1El..En. Electroic Engineering Spa · 2019
- 1 generation backK211091 Deka Tiac IIEl.En Electronic Engineering Spa · 2021
- This deviceK260647 SpecchioEl.En S.P.A. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K122389 | Trusculpt | Cutera, Inc. | 2012 | 1 |
| −4 | K132949 | Pellefirm | Ellman International, Inc. | 2014 | — |
| −3 | K143040 | Exilis XP | BTL Industries, Inc. | 2015 | — |
| −2 | K183371 | Deka Tiac 1 | El..En. Electroic Engineering Spa | 2019 | — |
| −1 | K211091 | Deka Tiac II | El.En Electronic Engineering Spa | 2021 | — |
| 0 (this device) | K260647 | Specchio | El.En S.P.A. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PBX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211091 | Deka Tiac IISummary page 5…78.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Predicate Device: DEKA TIAC II (K211091) Device Description: The SPECCHIO is a medical device that used high frequency RF currents to produce a localized increase in t… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
The SPECCHIO RF device is intended to provide heating for the purpose of elevating tissue temperature
for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local
circulation.
The SPECCHIO massage device is intended to provide a temporary reduction in the appearance of
cellulite.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260647: Specchio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260647
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026