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FDA 510(k)

LED Light Therapy Machine (G1, G3, G4, G6)

K-Number: K242638 · 2024-11-27

ApplicantShenzhen Walton Technology Co., Ltd.
Decision Date2024-11-27
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Machine (G1, G3, G4, G6) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Walton Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K242638. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED Light Therapy Machine (G1, G3, G4, G6)?

LED Light Therapy Machine (G1, G3, G4, G6) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Shenzhen Walton Technology Co., Ltd.. The 510(k) number is K242638.

When did LED Light Therapy Machine (G1, G3, G4, G6) receive FDA 510(k) clearance?

LED Light Therapy Machine (G1, G3, G4, G6) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K242638.

Who is the listed applicant for LED Light Therapy Machine (G1, G3, G4, G6)?

The FDA 510(k) record lists Shenzhen Walton Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Machine (G1, G3, G4, G6)?

The FDA product code for LED Light Therapy Machine (G1, G3, G4, G6) is OHS.

Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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