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510(k) Data Aggregation

K Number

Device Name

KALA MINI 2.0 (KALA-04)

Manufacturer

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Date Cleared

2025-09-04

(85 days)

Product Code

Regulation Number

Type

Panel

General and Plastic Surgery (SU)

Reference & Predicate Devices

N/A

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Device Name :

KALA MINI 2.0 (KALA-04)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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