StarFormer, TightWave
FDA 510(k) K221274 · Fotona D.O.O.
510(k) numberK221274
Submission
- Device name
- StarFormer, TightWave
- Applicant
- Fotona D.O.O.
Ljubljana, SI - Received
- May 2, 2022
- Decision date
- September 29, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
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| K202985 | LightWalker Laser System FamilyGEX · Traditional | 03/19/2021SE |
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Questions and answers
When was StarFormer, TightWave cleared by the FDA?
StarFormer, TightWave (K221274) received a 510(k) decision of Substantially Equivalent on September 29, 2023, 515 days after the submission was received.
What is the product code of K221274?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.