# K221274: StarFormer, TightWave

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Sep 29, 2023 after 515 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K062439 (2007). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973929: Neotonus MS-101 Magnetic Muscle Stimulator System, Neotonus, Inc. (1998) Summary page 4.
- K131291: Torc Body, Johari Digital Healthcare, Ltd. (2013) Summary page 4.

## Most influential descendants
- K241785: StarFormer (M008-3T) (2025), 0 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K221274
Methodology: https://510kreport.com/methodology