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Found 10 results
510(k) Data Aggregation
K Number
K994014Device Name
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
2000-02-24
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ESC Intense Pulsed Light Systems: EpiLight® and MultiLight™, are used for the removal of unwanted hair from all skin types.
Device Description
Not Found
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K Number
K991935Device Name
EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
2000-01-27
(232 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EpiLight® and PhotoDerm® HR are used for the removal of unwanted hair. EpiLight® and PhotoDerm® HR are also intended to effect stable long-term, or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
Device Description
EpiLight® and PhotoDerm® HR are electro-optical medical devices designed for effective photothermal treatment of unwanted hair and its removal.
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K Number
K982119Device Name
DIODE LASER
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1999-02-04
(233 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESC Diode Laser System is intended for the treatment of vascular and pigmented lesions including leg veins.
Device Description
The ESC Diode Laser System is a semiconductor diode laser system operating at the 830nm wavelength
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K Number
K974536Device Name
PHOTODERM HR SYSTEM
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1998-05-20
(169 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhotoDerm® HR is intended for the removal of unwanted hair.
The PhotoDerm® HR is used for the removal of unwanted hair.
Device Description
PhotoDerm® HR is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its removal.
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K Number
K980537Device Name
ND: YAG ACCESSORY FOR PHOTODERM SYSTEM
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1998-04-15
(63 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhotoDerm® Nd: YAG accessory is intended for coagulation and hemostasis of vascular lesions and soft tissue.
Device Description
The Nd: YAG laser accessory is a pulsed medical laser operating at a wavelength of 1064 nanometers. The device is operated by the PhotoDerm® system and emits high energy pulses of 1- 10 ms duration and up to 150 j/cm2. The Nd: YAG laser accessory is a hand held device that replaces the standard optical treatment head used in the PhotoDerm® machines.
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K Number
K972872Device Name
DERMA K LASER SYSTEM
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1997-10-28
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.
Device Description
The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.
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K Number
K972028Device Name
DERMASCAN SURGICAL LASER SCANNER
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1997-10-24
(144 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DermaScan™ Surgical Laser Scanner is intended for use in soft tissue ablation procedures.
Device Description
DermaScan™ Surgical Laser Scanner is a microprocessor controlled device that converts a surgical laser device into an advanced aesthetic surgery tool for a variety of cosmetic procedures. The device uses motorized mirrors to deflect a laser beam over a specified area in a uniform and controlled manner. Using a sophisticated interface the user can specify a large number of parameters to achieve a scanning procedure that is tailored to the individual needs of the patient. The scanner then controls the actual tissue ablation process to achieve a uniform removal of tissue over the entire area. An aiming beam is used to outline the treated area
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K Number
K963249Device Name
EPILIGHT HAIR REMOVAL SYSTEM
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1997-07-07
(322 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EpiLight™ Hair Removal System is intended for long term removal of unwanted hair.
The EpiLight TM Hair Removal System is used for the removal of unwanted hair
Device Description
EpiLight™ Hair Removal System is an electro optic medical device designed for effective photothermal treatment of unwanted hair and its long-term removal
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K Number
K964253Device Name
DERMA 20 LASER SYSTEM
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1997-04-11
(169 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Incision, excision, ablation, vaporization and hemostasis of soft tissue
Device Description
Derma™ 20 is a pulsed medical laser system incorporating an Er:YAG laser, operating at a wavelength of 2.94 microns. The device emits pulses of up to 1.7 joules on tissue. The pulse width is 350 μsec, the pulse rate is 5-12 pulses per second. The system is composed of the following units: • Laser optical rail assembly • Articulated arm • Power supply and pulse forming network (PFN) • Cooling system • Control electronics system • Power distribution box
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K Number
K960772Device Name
PHOTODERM PL.
Manufacturer
ESC MEDICAL SYSTEMS LTD.
Date Cleared
1996-09-11
(198 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ESC MEDICAL SYSTEMS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhotoDerm PL is a system intended for the treatment of benign pigmented lesions and tattoos.
Device Description
PhotoDerm PL is an electro optic medical device designed for effective photothermal treatment of benign pigmented lesions and tattoos non-invasively.
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