Specchio
FDA 510(k) K260647 · El.En S.P.A.
510(k) numberK260647
Submission
- Device name
- Specchio
- Applicant
- El.En S.P.A.
Calenzano, IT - Received
- February 27, 2026
- Decision date
- April 2, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
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More from Indiba S. A. U.
| 510(k) | Device | Decision |
|---|---|---|
| K251432 | OloGEX · Traditional | 08/06/2025SE |
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| K241459 | MOTUS PRO FamilyGEX · Special | 06/21/2024SE |
| K240752 | Deka ToroGEX · Traditional | 05/16/2024SE |
| K233473 | Deka LotusONF · Traditional | 05/16/2024SE |
| K234057 | NirvanaGEX · Traditional | 04/10/2024SE |
| K240537 | Smartxide ProGEX · Special | 03/20/2024SE |
| K240497 | Smartxide Tetra ProGEX · Special | 03/12/2024SE |
| K233470 | Deka LilyNGX · Traditional | 12/19/2023SE |
Questions and answers
When was Specchio cleared by the FDA?
Specchio (K260647) received a 510(k) decision of Substantially Equivalent on April 2, 2026, 34 days after the submission was received.
What is the product code of K260647?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.