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510(k) Data Aggregation
K Number
K030508Device Name
DEPILASE TRIO LASE LASER SYSTEM
Manufacturer
DEPILASE GROUP LTD.
Date Cleared
2003-05-20
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DEPILASE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions ( 532 and 1064 nm ), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).
Device Description
The DEPILASE TRIO LASE Laser System is based on Nd: YAG and Alexandrite Jaser technology. Within the same system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.
The DEPILASE TRIO LASE Laser System is designed with 6 major sub-systems:
- a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
- c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
- d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
- e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
- The microprocessor based controller which regulates the functions of the laser and allows f) parameter selection by the user.
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K Number
K030510Device Name
DEPILASE TWIN YAG LASER SYSTEM
Manufacturer
DEPILASE GROUP LTD.
Date Cleared
2003-05-14
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DEPILASE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths), the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and the dermatological use for the non invasive treatment of facial wrinkles (1064 nm wavelength).
Device Description
The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by passing with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE TWIN YAG Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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K Number
K030506Device Name
DEPILASE YAG LASE PLUS LASER SYSTEM
Manufacturer
DEPILASE GROUP LTD.
Date Cleared
2003-05-09
(79 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DEPILASE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and for the use in dermatological applications for the treatment of facial wrinkles.
Device Description
The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal. which is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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K Number
K020697Device Name
DEPILASE TWIN YAG LASER SYSTEM
Manufacturer
DEPILASE GROUP LTD.
Date Cleared
2002-04-12
(39 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DEPILASE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions( 1064 and 532 nm wavelengths) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (1064 nm wavelength).
Device Description
The DEPILASE TWIN YAG Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by warelonging with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using (SHO). The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE TWIN YAG Laser System is designed with 5 major sub-systems:
- a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
- c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
- d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
- e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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K Number
K020463Device Name
DEPILASE YAG LASE PLUS LASER SYSTEM
Manufacturer
DEPILASE GROUP LTD.
Date Cleared
2002-02-27
(15 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DEPILASE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types.
Device Description
The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.
The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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K Number
K020412Device Name
DEPILASE TWIN LASE LASER SYSTEM
Manufacturer
DEPILASE GROUP LTD.
Date Cleared
2002-02-22
(15 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DEPILASE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEPILASE TWIN LASE Laser System is indicated for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.
Device Description
The DEPILASE TWIN LASE Laser System is based on Nd: YAG and Alexandrite laser technology. Within the system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.
The DEPILASE TWIN LASE Laser System is designed with 6 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
f) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
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K Number
K001990Device Name
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
Manufacturer
DEPILASE GROUP LTD.
Date Cleared
2000-10-23
(116 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DEPILASE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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