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FDA 510(k)

LightStim Elipsa

K-Number: K212771 · 2022-01-26

ApplicantLed Intellectual Properties, LLC
Decision Date2022-01-26
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LightStim Elipsa is the device name listed in this FDA 510(k) record. The listed applicant is Led Intellectual Properties, LLC. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212771. 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 LightStim Elipsa?

LightStim Elipsa is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Led Intellectual Properties, LLC. The 510(k) number is K212771.

When did LightStim Elipsa receive FDA 510(k) clearance?

LightStim Elipsa received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212771.

Who is the listed applicant for LightStim Elipsa?

The FDA 510(k) record lists Led Intellectual Properties, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LightStim Elipsa?

The FDA product code for LightStim Elipsa is OHS.

Other records listing Led Intellectual Properties, LLC as applicant

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.

K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)K153399LightStim Professional LED Bed

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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