510(k) · Cleared
ClearedStarFormer (M008-3T)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.O.O. · QPL Electromagnetic Stimulator, Pain Relief
Cleared on Mar 27, 2025 as substantially equivalent to K230014 (Tonica Elektronik A/S, 2023) and 2 other predicates after a 280-day review. Its family tree reaches back 7 generations to 1999.
- Decided
- Mar 27, 2025
- Review
- 280 days
- Class
- Class II
- Product code
- QPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K984142 (1999). 22 ancestors in all, the oldest K940301 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK984142 Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994…Mettler Electronics Corp. · 1999
- 6 generations backK071137 Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
- 5 generations backK093138 MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001…Shenzhen Dongdixin Technology Co., Ltd. · 2010 · Recalled
- 4 generations backK113010 FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens StimulatorFamidoc Technology Co., Ltd. · 2012
- 3 generations backK181688 R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS…Shenzhen Roundwhale Technology Co., Ltd. · 2018
- 2 generations backK210021 Axon TherapyNeuralace Medical, Inc. · 2021
- 1 generation backK230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption…Tonica Elektronik A/S · 2023
- This deviceK241785 StarFormer (M008-3T)Fotona D.O.O. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K984142 | Sonicator Plus 992, Model Number ME 992 and Sonicator Plus 994, Model Number… | Mettler Electronics Corp. | 1999 | — |
| −6 | K071137 | Sonicator Plus 940, Model ME940 | Mettler Electronics Corp. | 2007 | — |
| −5 | K093138 | MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and… | Shenzhen Dongdixin Technology Co., Ltd. | 2010 | 1 |
| −4 | K113010 | FDES100(Tens and Ems Stimulator, FDES102(ED402) Tens Stimulator | Famidoc Technology Co., Ltd. | 2012 | — |
| −3 | K181688 | R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator | Shenzhen Roundwhale Technology Co., Ltd. | 2018 | — |
| −2 | K210021 | Axon Therapy | Neuralace Medical, Inc. | 2021 | — |
| −1 | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100… | Tonica Elektronik A/S | 2023 | — |
| 0 (this device) | K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
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 QPL? 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 QPL device
- #1 K230014 MagVenture Pain Therapy: MagPro R30, MagPro…score 16.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K230014 | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100…Summary page 5…Associated Product Code(s): IPF, NGX Panel: Neurology 3. PREDICATE DEVICEIDENTIFICATION K230014 MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagP… | 2023 |
| * | K163393 | Hi-Dow Wireless TENS/EMS System (Model HD-5N)Summary page 5…MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption K163393 Hi-Dow Wireless TENS/EMS System (Model HD-SN)… | 2017 |
| * | K221274 | StarFormer, TightWaveSummary page 5…K163393 Hi-Dow Wireless TENS/EMS System (Model HD-SN) K221274 StarFormer 4. DEVICE DESCRIPTION: StarFormer is a non-invasive therapeutic device. The… | 2023 |
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 26 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 22 ancestors have a recall of any class.
- 2 other devices also cite its predicate K230014.
How does its category compare?
All QPL devicesQPL Electromagnetic Stimulator, Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QPL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QPL
185in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPL
No recall names QPL since 2007.
Adverse event reports per year · QPL
1in 2021
MAUDE reports naming product code QPL, 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 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 3 | 185 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
• With handheld applicators: PMS mode: Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes -…
Read the full statement (203 words)
• With handheld applicators:
PMS mode:
Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance.
Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy.
Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation.
TENS mode:
Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.
Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
• With Chair Back applicator:
TENS mode:
Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.
Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241785: StarFormer (M008-3T).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241785
Report an extraction error
Are you the manufacturer?
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