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510(k) Data Aggregation
K Number
K150282Device Name
Shaser Skin Beauty Intense Pulsed Light System Family for Acne
Manufacturer
SHASER, INC.
Date Cleared
2015-05-27
(111 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Device Description
Shaser Skin Beauty Intense Pulsed Light System Family For Acne is an Over-The-Counter, Light-Based Acne Clearing Device. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger/AC cord. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. The Principle of Operation is both photochemical and photothermal. The Mechanism of Action is to stimulate oxygen production which attacks p.acne and to reduce inflammation due to acne.
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K Number
K142924Device Name
Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
Manufacturer
SHASER, INC.
Date Cleared
2015-02-13
(128 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for:
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosecea, erythema of rosacea, angiomas, poikiloderma of Civate, leg veins and venous malformations.
Device Description
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family devices are prescription home use, light-based skin care systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Action is to lighten or resolve lesions using light for preferentially heating. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
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K Number
K141583Device Name
SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
Manufacturer
SHASER, INC.
Date Cleared
2014-07-22
(39 days)
Product Code
ONF, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser Skin Beauty Intense Pulsed Light System Family is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
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K Number
K140631Device Name
LUMENA FH HAIR REMOVAL SYSTEM
Manufacturer
SHASER, INC.
Date Cleared
2014-05-16
(65 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Lumena FH is an over the counter device intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Lumena FH is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
Over-The-Counter, AC Powered, Personal Light-Based Hair Removal System. Emission activation is by fingerswitch. Device includes a limited life lamp cartridge. Overall weight of the device is 1.0 Kg, and the size is 22 x 16 x 78 cm (HxWxD). The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A single phase.
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K Number
K133201Device Name
SHASER V-MINI 2 HAIR REMOVAL SYSTEM
Manufacturer
SHASER, INC.
Date Cleared
2014-02-12
(118 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SHASER V-MINI 2 is intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser V-MINI 2 is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
Shaser V-MINI 2 is an Over-The-Counter, Cordless, Rechargeable Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
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K Number
K132170Device Name
SHASER V-MINI RX
Manufacturer
SHASER, INC.
Date Cleared
2013-11-26
(134 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shaser V-MINI RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser V-MINI RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX Hair Removal System is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
Shaser V-MINI RX is an IPL device with a wavelength range of 400- 1200 nm. The proposed device removes hair by way of Selective Photothermolysis; the preferential thermal treatment of target tissue without collateral effect of surrounding tissue. The pulsed light heats the hair bulb which disables hair growth. The proposed device is intended for males and females to remove unwanted hair from body sites (legs, arms, chest, underarms, stomach, and bikini line) and from facial sites (chin, cheek, chin, neck, side burns, and above the lips). The V-MINI RX is a battery powered, portable device. Electrical requirement (battery charger) is 115 VAC, 15A, 50-60 Hz, single phase.
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K Number
K132266Device Name
SHASER HRS2 RX HAIR REMOVAL SYSTEM
Manufacturer
SHASER, INC.
Date Cleared
2013-09-30
(70 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shaser HRS2 RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser HRS2 RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types 1 - IV. The Shaser HRS2 RX Hair Removal System is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
Shaser HRS2 RX is an IPL device with a wavelength range of 400-1200 nm. The HRS2 RX is an AC powered, portable device. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
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K Number
K130015Device Name
SHASER V-MINI HAIR REMOVAL SYSTEM
Manufacturer
SHASER, INC.
Date Cleared
2013-06-13
(161 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SHASER HRS3 hair removal system is an over the counter device intended for removal of unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
Over-The-Counter, Cordless, Rechargable, Personal Light-Based Hair Removal System For Permanent Hair Reduction. Emission activation is by fingerswitch. Includes limited life treatment head and battery charger. Overall weight of the device is 0.45 Kg, and the size is 2.1 x 0.6 x 0.8 cm (HxWxD). Charger Electrical Requirement is 115 VAC, 15A, 50-60 Hz, single phase.
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K Number
K120080Device Name
SHASER HRS2 HAIR REMOVAL SYSTEM
Manufacturer
SHASER, INC.
Date Cleared
2012-05-25
(135 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SHASER HRS2 Hair Removal System is an over-the-counter device intended for removal of unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-growing when measured at 6, 9, and12 months after the completion of a treatment regimen.
Device Description
The SHASER HRS2 Hair Removal System is a personal, light-based, hair reduction system intended to be sold over-the-counter directly to the end user. The device provides permanent hair reduction as defined below using Intense Pulsed Light (IPL) technology.
The SHASER HRS2 Hair Removal System consists of a powered base unit and a tethered hand piece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light carring a cloth, and user's manual.
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K Number
K103560Device Name
SHASER IPL HAIR REMOVAL SYSTEM
Manufacturer
SHASER, INC.
Date Cleared
2011-05-18
(166 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SHASER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SHASER IPL Hair Removal System is an over the counter device intended for removal of unwanted hair.
Device Description
The SHASER IPL Hair Removal System is a personal, light-based, hair reduction system intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The SHASER IPL Hair Removal System consists of a powered base unit and a tethered handpiece from which the IPL flashes are delivered to the patient's skin. The system will be sold with light cartridges, cleaning cloth, and user's manual.
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