510(k) · Cleared
ClearedStarFormer, TightWave
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fotona D.O.O. · IPF Stimulator, Muscle, Powered
Cleared on Sep 29, 2023 as substantially equivalent to K973929 (Neotonus, Inc., 1998) and 1 other predicate after a 515-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Sep 29, 2023
- Review
- 515 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K062439 (2007). 3 ancestors in all, the oldest K973929 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK062439 Powertone, Model PT-11Johari Digital Healthcare, Ltd. · 2007
- 1 generation backK131291 Torc BodyJohari Digital Healthcare, Ltd. · 2013
- This deviceK221274 StarFormer, TightWaveFotona D.O.O. · 2023
- Descendant · cites it directly · 0 of its ownK241785 StarFormer (M008-3T)Fotona D.O.O. · 2025
Most influential descendants
Showing 1 of 1 · See all- K241785StarFormer (M008-3T)Fotona D.O.O. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K062439 | Powertone, Model PT-11 | Johari Digital Healthcare, Ltd. | 2007 | — |
| −1 | K131291 | Torc Body | Johari Digital Healthcare, Ltd. | 2013 | — |
| 0 (this device) | K221274 | StarFormer, TightWave | Fotona D.O.O. | 2023 | — |
| +1 | K241785 | StarFormer (M008-3T) | Fotona D.O.O. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K973929 | Neotonus MS-101 Magnetic Muscle Stimulator SystemSummary page 4…Powered 21 CFR 890.5850, Class II Product Code: IPF, NGX PREDICATE DEVICES - Neotonus MS-101 Magnetic Muscle Stimulator System (K973929) - Johari Digital Healthcare Ltd., TORC BODY (K131291) DEVICE DESCRIPTION SUMMARY StarFormer is a non-invasive therapeuti… | 1998 |
| * | K131291 | Torc BodySummary page 4…roduct Code: IPF, NGX PREDICATE DEVICES - Neotonus MS-101 Magnetic Muscle Stimulator System (K973929) - Johari Digital Healthcare Ltd., TORC BODY (K131291) DEVICE DESCRIPTION SUMMARY StarFormer is a non-invasive therapeutic device. The device comprises a magnetic stimulation coil l… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241785 | StarFormer (M008-3T) | 2025 | 0 |
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 16 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K241785 (Fotona D.O.O., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K973929.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes. -Relaxation of muscle spasm, -Prevention or retardation of disuse atrophy, -Increasing local blood circulation, -Muscle re-education, -Immediate post-surgical…
Read the full statement (103 words)
Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
Fotona StarFormer is indicated for use in stimulating neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes.
-Relaxation of muscle spasm,
-Prevention or retardation of disuse atrophy,
-Increasing local blood circulation,
-Muscle re-education,
-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
-Maintaining or increasing range of motion.
Fotona StarFormer is indicated for improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen
-Strengthening, Toning and Firming of buttocks and thighs
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221274: StarFormer, TightWave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221274
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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