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FDA 510(k)

Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72

K-Number: K163329 · 2017-04-14

ApplicantPulsaderm, LLC
Decision Date2017-04-14
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 is the device name listed in this FDA 510(k) record. The listed applicant is Pulsaderm, LLC. It received FDA 510(k) clearance on 2017-04-14 under 510(k) number K163329. 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 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72?

Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 is a medical device that received FDA 510(k) clearance on 2017-04-14. The listed applicant is Pulsaderm, LLC. The 510(k) number is K163329.

When did Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 receive FDA 510(k) clearance?

Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 received FDA 510(k) clearance on 2017-04-14, under 510(k) number K163329.

Who is the listed applicant for Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72?

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

What is the FDA product code for Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72?

The FDA product code for Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 is OHS.

Other records listing Pulsaderm, 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.

K182501Hair Laser HeadbandK170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

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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