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FDA 510(k)

B.Light Clear Evo and B.Light Restore Evo

K-Number: K223919 · 2023-09-23

ApplicantBemer Int AG
Decision Date2023-09-23
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

B.Light Clear Evo and B.Light Restore Evo is the device name listed in this FDA 510(k) record. The listed applicant is Bemer Int AG. It received FDA 510(k) clearance on 2023-09-23 under 510(k) number K223919. 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 B.Light Clear Evo and B.Light Restore Evo?

B.Light Clear Evo and B.Light Restore Evo is a medical device that received FDA 510(k) clearance on 2023-09-23. The listed applicant is Bemer Int AG. The 510(k) number is K223919.

When did B.Light Clear Evo and B.Light Restore Evo receive FDA 510(k) clearance?

B.Light Clear Evo and B.Light Restore Evo received FDA 510(k) clearance on 2023-09-23, under 510(k) number K223919.

Who is the listed applicant for B.Light Clear Evo and B.Light Restore Evo?

The FDA 510(k) record lists Bemer Int AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B.Light Clear Evo and B.Light Restore Evo?

The FDA product code for B.Light Clear Evo and B.Light Restore Evo is OHS.

Other records listing Bemer Int AG 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.

K231368Bemer Therapy System EvoK210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetK151834BEMER Classic Set, BEMER Pro-Set

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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