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510(k) Data Aggregation
K Number
K251493Device Name
Skin Clinic Freeze Point for Warts and Skin Tags
Manufacturer
CryoConcepts LP
Date Cleared
2025-05-22
(7 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skin Clinic Freeze Point product is intended for the treatment of common warts, plantar warts, and skin tags by OTC consumers. Treat skin tags in adults age 22 years or older
Device Description
Not Found
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K Number
K242932Device Name
Skin Clinic Nitro Clear Wart Remover
Manufacturer
CryoConcepts LP
Date Cleared
2025-04-15
(202 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skin Clinic Nitro Clear Wart Remover is intended for the OTC treatment of common warts and plantar warts in adults and children 4 years of age and older.
Device Description
The Skin Clinic Nitro Clear Wart Remover device utilizes extreme cold to facilitate the removal of common and plantar warts by freezing. Each device contains a container of cryogen gas in a plastic holder along with instructions for use. The Skin Clinic Nitro Clear Wart Remover device is for OTC use and utilizes Nitrous Oxide cryogen delivered from the cartridge into a tip which acts as a reservoir for the cryogen gas. The applicator tip is cooled to as low as -89°C. Depending on the location and size, the applicator is placed against the common wart or plantar wart between 10-40 seconds which freezes the targeted area. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
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K Number
K242625Device Name
Freeze Point & Private Label Versions
Manufacturer
CryoConcepts LP
Date Cleared
2024-10-25
(52 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Skin Clinic Freeze Point product is intended for the treatment of common and plantar warts by OTC consumers. May be used with children 4 years of age or older under adult supervision.
Device Description
The Skin Clinic Freeze Point device utilizes extreme cold to facilitate the removal of warts and by freezing. Each kit contains a container of cryogen gas in a plastic holder and instructions for use. The device is for OTC use and utilizes difluoroethane cryogen delivered from the canister into a foam wrapped tip which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to as low as -50°C. The applicator is then placed against the wart for up to 40 seconds which freezes the targeted tissue. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
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K Number
K240106Device Name
Histofreezer V
Manufacturer
CryoConcepts LP
Date Cleared
2024-06-10
(146 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Histofreezer V indications for use as follows: l, 1,1,2-tetrafluoroethane, pentafluoroethane, and l, 1,1-tri fluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratoses, actinic keratosis, achrochorodon, molluscum contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, Porokeratosis Plantaris, Angiomas, Keratoacanthoma, chrondrodermatitis, epithelial nevus, Leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Device Description
The Histofreezer V device utilizes extreme cold to facilitate the removal of benign topical lesions. The device utilizes a combination of 1.1.1.2-Tetrafluoroethane. Pentafluoroethane, and 1,1,1-Trifluoroethane delivered from the cannister of gas into a foam bud or cone which acts as a reservoir for the cryogen gas. To perform the treatment the bud or cone facilitates freezing the targeted lesion for up to 40 seconds .. The frozen lesion falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
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K Number
K211099Device Name
Freezen Clear Skin Clinic Warts & Tags
Manufacturer
CryoConcepts LP
Date Cleared
2022-06-17
(430 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product is intended for the OTC treatment of common warts, plantar warts, and skin tags.
Device Description
The Freeze 'n Clear Skin Clinic for Warts and Skin Tags product utilizes extreme cold to facilitate the removal of warts and skin tags by freezing. Each kit contains a container of cryogen gas, foam applicators, tweezers and instructions for use. The device is for OTC use and utilizes a combination of dimethyl ether, propane and isobutane delivered from the canister into a foam applicator which acts as a reservoir for the cryogen gas. The gas rapidly evaporates and cools the applicator to approximately -55°C. The applicator is then placed against the wart or skin tag for 40 seconds which freezes the targeted tissue. The frozen skin tag or wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.
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K Number
K190407Device Name
CryoLab
Manufacturer
CryoConcepts LP
Date Cleared
2019-04-22
(60 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryoLab® is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum ●
- Skin Tags ●
- Actinic Keratosis ●
- Lentigo
- Verruca Plana ●
- Verruca Vulgaris ●
- Verruca Plantaris
- Genital Lesions ●
- Seborrheic Keratosis
Device Description
The CryoLab® device is designed to electronically control a timed dispense of cryogen gas when actuated. The device contains no software and uses a cylinder of nitrous oxide or carbon dioxide. Licensed Practitioners can dispense the gas for use in procedures requiring the surgical destruction of target tissue using the extreme cold of nitrous oxide, N2O (-89°C) or carbon dioxide, CO2 (-79°).
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K Number
K183601Device Name
CryoTouch
Manufacturer
CryoConcepts LP
Date Cleared
2019-04-18
(113 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryoTouch™ is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures.
The list below shows examples of the types of lesions that may be treated:
- Verruca (warts) ●
- Plantar warts
- Seborrheic Keratoses
- Actinic Keratoses
- Achrochordon ●
- Molluscum Contagiosum ●
- Age Spots
- Dermafibroma
- Small Keloids ●
- Granuloma Annulare ●
- Porokeratosis Plantaris ●
- Angiomas
- Lentigo Maligna
- Keratoacanthoma
- Basal Cell Carcinomas ●
- Bowen's Disease
- Lentigo Discrete
- Chondrodermatitis
- Epithelial Nevus
- Leukoplakia ●
- Granuloma Pyogenicum ●
- Kaposi's Sarcoma ●
- o Pyogenic Granuloma
Device Description
The CryoTouch™ device gently dispenses cryogen gas into an applicator or a uniquely designed cone. The applicator or cone is then used to apply the extreme cold to the lesion being treated to effect cryosurgical treatment.
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K Number
K172769Device Name
CryOmega Flexx
Manufacturer
CryoConcepts LP
Date Cleared
2017-11-30
(78 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
CryoConcepts LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum
- · Skin Tags
- · Actinic Keratosis
- Lentigo
- · Verruca Plana
- · Verruca Vulgaris
- Verruca Plantaris
- · Genital Lesions
- · Seborrheic Keratosis
Device Description
The CryOmega Flexx device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses a 16g or 25g cartridge of nitrous oxide that is sprayed once the gas cartridge has been screwed onto the applicator. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N2O (-89ºC).
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