# K241785: StarFormer (M008-3T)

- Pathway: 510(k) (Traditional)
- Applicant: Fotona D.O.O.
- Decided: Mar 27, 2025 after 280 days
- Product code: QPL (Electromagnetic Stimulator, Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K984142 (1999). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230014: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, Tonica Elektronik A/S (2023) Summary page 5.
- K163393: Hi-Dow Wireless TENS/EMS System (Model HD-5N), Hi-Dow International, Inc. (2017) Summary page 5.
- K221274: StarFormer, TightWave, Fotona D.O.O. (2023) Summary page 5.

## Indications for use
• 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.

Source page: https://510kreport.com/device/K241785
Methodology: https://510kreport.com/methodology