FDA 510(k) Search

K Number

K250761

Device Name

KALA Therapy Wand (Model: KALA-03)

Manufacturer

SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD

Date Cleared

2025-07-11

Product Code

OHS, ISA, OLP

Regulation Number

878.4810

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

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Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

null

Therapeutic

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Diagnostic

null

SaMD (Software as a Medical Device)

null

IVD (In Vitro Diagnostic)

null

PCCP (Predetermined Change Control Plan) Authorized

null

Overview

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Summary

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