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510(k) Data Aggregation
K Number
K231216Device Name
POTENZA
Manufacturer
Jeisys Medical Inc.
Date Cleared
2024-12-10
(592 days)
Product Code
GEI, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Jeisys Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at IMHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode.
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K Number
K231287Device Name
POTENZA
Manufacturer
Jeisys Medical Inc.
Date Cleared
2024-11-05
(551 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Jeisys Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode. The NEW POTENZA consists of the following components: Electrosurgical Unit - Main body, handpieces (Predicate Device have Motor, AC handpieces), electrode tips for the handpiece – Add three non-invasive tips connect to S handpiece, Neutral electrode pad and neutral electrode pad cable, cleared under K201685, Handpiece stand, Foot switch, Power cord.
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K Number
K230663Device Name
Density
Manufacturer
Jeisys Medical Inc.
Date Cleared
2023-08-14
(157 days)
Product Code
GEI, ISA
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Jeisys Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The DENSITY generates radiofrequency (RF) energy by means of high RF at 6.78MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coaqulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.
The DENSITY is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis.
The DENSITY consists of the following components:
•Electrosurgical Unit - Main body
•Handpiece
•6 different electrode tips
•Neutral electrode pad and neutral electrode pad cable, cleared under K201685
•Foot switch
•Power cord
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K Number
K183284Device Name
INTRAcel RF Microneedle System
Manufacturer
Jeisys Medical Inc.
Date Cleared
2020-01-15
(415 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Jeisys Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures for electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin in monopolar and bipolar mode.
Device Description
The INTRAcel RF Microneedle System comprises of two primary components; an RF Generator with User Interface Software and a disposable Electrode Insertion Device with an integrated cable.
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K Number
K162169Device Name
EdgeOne CO2 Laser
Manufacturer
Jeisys Medical Inc.
Date Cleared
2016-10-27
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Jeisys Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Device Description
The Jeisys EdgeOne CO2 Laser is comprised of the following major components:
1. The main console unit
2. Delivery handpieces (2 surgical and one fractional)
3. Footswitch.
4. Accessories
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