INDIBA COMPACT devices— 510(k) K243164

Substantially Equivalent

Indiba S. A. U.

FDA 510(k) clearance K243164 for INDIBA COMPACT devices, Substantially Equivalent on 2024-11-20. Applicant: Indiba S. A. U.. Device class: 2.

Clearance details

Applicant: Indiba S. A. U.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2024-09-30
Decision date: 2024-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sant Quirze Del Vallès, ES

Download summary PDF View on FDA.gov ↗

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K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

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Data sourced from openFDA. This site is unofficial and independent of the FDA.