← Product Code [PBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX) · K260647

# SPECCHIO (K260647)

_El.En S.P.A. · PBX · Apr 2, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K260647

## Device Facts

- **Applicant:** El.En S.P.A.
- **Product Code:** [PBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX.md)
- **Decision Date:** Apr 2, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K260647](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PBX/K260647)

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