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510(k) Data Aggregation
K Number
K243780Device Name
HELIOS 785 Pico (1754V2)
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2025-02-07
(60 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
[Indications for use of Q-switched Nd:YAG Laser]
1064 nm (including RTP 1064 mode):
- Incision, excision, ablation, vaporization of soft tissue for general dermatology
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment melasma
- Treatment of Pigmented Lesions
- · nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- dark ink: black, blue and brown
532 nm:
- Treatment of Vascular Lesions
- · port wine birthmarks
- · telangiectaias
- · spider angioma
- · cherry angioma
- · spider nevi
- Treatment of Pigmented Lesions
- · café-au-lait birthmarks
- · solar lentiginos
- · senile lentiginos
- · becker's nevi
- · freckles
- nevus spilus
- nevus of ota
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Tattoo Removal
- · light ink: red, sky blue, green, tan, purple, and orange
[Indications for use of FR mode in Nd:YAG Laser]
- Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB (Pseudofollicultis Barbae). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
- Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins
- Coagulation and hemostasis of soft tissue
- Treatment of wrinkles
[Indications for use of Ti:Sapphire Laser]
785nm:
- Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously *
Device Description
The flash lamp as a laser pumping source converts electric energy to light energy when a high voltage is applied. Nd:YAG crystal with the specific resonator emits an 1064nm single wavelength laser by absorbing light energy from the flash lamp. Q-switching mode is applied to the 1064nm laser resonator to amplify the 1064nm laser with about 10ns short pulse width.
The amplified O-switched 1064nm laser is secondarily amplified by an another Nd: YAG crystal and, then is converted to a second harmonic 532nm laser by passing through KTP crystal.
Finally a 785nm laser is emitted by the 785nm cavity with Ti:Sapphire crystal using the 532nm laser as a laser pumping source.
HELIOS 785 Pico Laser System can emit 1064nm, 532nm, and 785nm laser selectively by switching the wavelength conversion optical modules. The 1064nm laser is emitted by only Nd: Y AG crystal resonator and the 532nm laser can be emitted with the 1064nm laser and KTP crystal. The 785nm laser can be emitted by all optical modules.
The Q-switch mode normally produces polarized light, but it is also possible to set the FR(Free Running) mode, which emits light in all directions by removing the optics of the Q-switch module. Additionally, the RTP(Real Twin Pulse) mode can be set to generate two identical pulses with a very short interval instead of a single pulse.
The HELIOS 785 Pico laser system consists of:
a) A high voltage power supply, which converts and rectifies Alternating Current (AC) 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) The micro processor based controller unit, which regulates the functions of both lasers and allows parameter selection by the user.
d) The Nd: YAG laser + Ti:sapphire laser head.
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K Number
K230373Device Name
HELIOS 785 Pico
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2023-05-22
(98 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
[Indication for use of Q-switched Nd:YAG Laser]
- Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm)
- Removal or lightening of unwanted hair with or without adjuvant preparation (1064nm)
- Tattoo Removal (1064nm, 532nm)
dark ink : blue and black (1064nm)
light ink : red, sky blue, green (532nm)
- Treatment of Benign Vascular Lesions (532nm)
port wine birthmarks
telangiectaias
spider angioma
cherry angioma
spider nevi
- Treatment of Benign Pigmented Lesions (1064nm, 532nm)
café-au-lait birthmarks (532nm)
solar lentiginos (532nm)
senile lentiginos (532nm)
becker's nevi (532nm)
freckles (532nm)
nevus spilus (532nm)
nevus of ota (1064nm)
[Indication for use of Ti:Sapphire Laser]
Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)
*Q-switched Nd:YAG Laser and Ti:Sapphire Laser cannot be used simultaneously.*
Device Description
HELIOS 785 Pico consists of a Q-switched Nd:YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm). The device consists of a main body, color touch screen, articulated arm, foot switch and several handpieces, and is controlled by an embedded processor. The device uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis to achieve its intended purpose. It is for prescription use only.
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K Number
K223588Device Name
PALLAS Premium
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2023-01-26
(56 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PALLAS Premium is Solid-State Ultraviolet laser system for treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Device Description
This device consists of a power supply unit, a cooling system, a controller, and a laser resonator, and is controlled by a microprocessor. When electric energy pumping is applied to the flash lamp, the laser is emitted through a device laser module that oscillates a laser with a wavelength of 311mm, and the laser is radiated through the end of the optical fiber, which is a laser carrier.
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K Number
K212663Device Name
HELIOS IV 785
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2022-06-09
(290 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
[Indication for use of Q-switched Nd:YAG Laser]
- Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064nm)
- Removal or lightening of unwanted hair with or without adjuvant preparation (1064mm)
- Tattoo Removal (1064nm, 532nm)
- dark ink : blue and black (1064nm)
- · light ink : red, sky blue, green (532nm)
- Treatment of Vascular Lesions (532nm)
- · port wine birthmarks
- · telangiectaias
- · spider angioma
- · cherry angioma
- · spider nevi
- Treatment of Pigmented Lesions (1064nm, 532nm)
- · café-au-lait birthmarks (532nm)
- · solar lentiginos (532nm)
- · senile lentiginos (532nm)
- · becker's nevi (532nm)
- · freckles (532nm)
- · nevus spilus (532nm)
- nevus of ota (1064nm)
[Indication for use of Ti:Sapphire Laser]
- Removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. (785nm)
* O-switched Nd: Y AG Laser and Ti:Sapphire Laser cannot be used simultaneously *
Device Description
HELIOS IV 785 consist of a set of Q-switched Nd: YAG (1064 nm) laser, frequency doubled KTP Nd:YAG (532 nm) laser, and Ti:Sapphire laser (785 nm), and controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
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K Number
K212573Device Name
PicoLO Premium
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2021-12-08
(114 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PicoLO Premium is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
<Tattoo removal mode>
1064nm
The 1064nm wavelength of the PicoLO Premium is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
532nm
The 532nm wavelength of the PicoLO Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
<PH mode> The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Device Description
PicoLO Premium is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Premium consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
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K Number
K203491Device Name
PicoLO Nd: YAG Picosecond Laser System
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2021-04-07
(131 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
<Tattoo Mode>
1064nm
The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
532nm
The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
<PH Mode>
The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The PicoLO laser system is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Device Description
The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of O-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
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K Number
K191501Device Name
PALLAS 308/311 Solid-State UV Laser System
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2020-01-03
(211 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
Device Description
Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.
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K Number
K183392Device Name
PicoLO Nd:YAG Picosecond Laser System
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2019-01-04
(28 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064nm
The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
532nm
The 532nm wavelength of the PicoLO laser system is indicated for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
Device Description
The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd: YAG Picosecond Laser System consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
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K Number
K182045Device Name
Lotus III Multi-Pulsed Er: Yag Laser System
Manufacturer
Laseroptek Co., Ltd.
Date Cleared
2018-12-27
(150 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LOTUS III Multi-Pulsed Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
Device Description
Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er: YAG lasers is controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
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