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Found 2 results

510(k) Data Aggregation

K Number

Device Name

CO2 Laser Therapy System (K106)

Manufacturer

HEBEI KEYLASER SCI-TECH Co.,Ltd

Date Cleared

2025-11-07

(88 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

Q-Switched Nd:Yag laser (K690)

Manufacturer

HEBEI KEYLASER SCI-TECH Co.,Ltd

Date Cleared

2025-11-06

(87 days)

Product Code

Regulation Number

Type

Panel

General & Plastic Surgery

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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