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FDA 510(k)

SHASER HRS2 HAIR REMOVAL SYSTEM

K-Number: K120080 · 2012-05-25

ApplicantShaser, Inc.
Decision Date2012-05-25
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHASER HRS2 HAIR REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shaser, Inc.. It received FDA 510(k) clearance on 2012-05-25 under 510(k) number K120080. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHASER HRS2 HAIR REMOVAL SYSTEM?

SHASER HRS2 HAIR REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-25. The listed applicant is Shaser, Inc.. The 510(k) number is K120080.

When did SHASER HRS2 HAIR REMOVAL SYSTEM receive FDA 510(k) clearance?

SHASER HRS2 HAIR REMOVAL SYSTEM received FDA 510(k) clearance on 2012-05-25, under 510(k) number K120080.

Who is the listed applicant for SHASER HRS2 HAIR REMOVAL SYSTEM?

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

What is the FDA product code for SHASER HRS2 HAIR REMOVAL SYSTEM?

The FDA product code for SHASER HRS2 HAIR REMOVAL SYSTEM is ONF.

Related Clinical Trials

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.

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Other records listing Shaser, Inc. 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.

K132170SHASER V-MINI RXK132266SHASER HRS2 RX HAIR REMOVAL SYSTEMK130015SHASER V-MINI HAIR REMOVAL SYSTEMK103560SHASER IPL HAIR REMOVAL SYSTEM

Related Devices (Code: ONF)

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.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., 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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