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510(k) Data Aggregation
K Number
K233374Device Name
Secret Pro
Manufacturer
ILOODA Co., Ltd
Date Cleared
2023-12-14
(73 days)
Product Code
GEI, GEX, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ILOODA Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
HF electrosurgical Part : The Secret Pro is intended for use in dermatologic and general surgical procedures for electro coaqulation and hemostasis
Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro coagulation and hemostasis
Device Description
Not Found
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K Number
K212561Device Name
MTX-C1
Manufacturer
ILOODA Co., Ltd
Date Cleared
2022-09-27
(410 days)
Product Code
GEI, PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ILOODA Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MTX-C1 is intended for the following medical condition; using three types of handpieces for delivery of non-thermal RF combined with massage:
- · Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- · Temporary reduction in the appearance of cellulite
Device Description
The MTX-C1 main unit is a RF(Radio-frequency) energy generator employed for a variety of aesthetic applications. The Main unit output is set and monitored via touchscreen and controlled by a footswitch.
The main unit can be used with 3 different types of handpieces for treatment.
The system consists of ;
1) Main unit
2) 3 type treatment handpiece
3) Footswitch
- 4) Touch screen(User interface)
The three treatment handpieces differ in size and configuration and are indicated for the treatment of various size areas.
The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit.
The handpiece is applied with a rubbing/massaging technique and the applicator should be moved continuously on the skin.
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K Number
K222555Device Name
reepot Nd; YAG laser system
Manufacturer
Ilooda Co., Ltd.
Date Cleared
2022-09-23
(31 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Ilooda Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reepot laser system is indicated for the incision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength :
- Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
Device Description
The reepot Nd;Y AG laser system is comprised of the following major components:
- 1) Laser system console
- 2) LCD control panel
- 3) VSLS handpieces (included camera and LCD display)
- 4) Footswitch.
- 5) Accessories
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K Number
K211000Device Name
ACUTRON
Manufacturer
ILOODA Co., Ltd
Date Cleared
2022-06-09
(433 days)
Product Code
GEI, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ILOODA Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Device Description
ACUTRON is High Frequency(=Radio Frequency, RF) includes the system main body, a handpieces with single-use micro-needle type electrodes, footswitch and an LCD touch screen control panel. The RF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the ACUTRON creates heat within the target dermal tissue via micro-needles inserted from the tip. The ACUTRON is consists of ; 1) Main unit 2) Smartcure handpiece(FDA cleared K182355) 3) Monopolar type micro-needle electrodes(FDA cleared K182355)
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K Number
K182355Device Name
Secret RF Smartcure Applicator with electrodes
Manufacturer
Ilooda Co., Ltd.
Date Cleared
2019-09-06
(372 days)
Product Code
GEI, KCW, ONQ, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Ilooda Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Device Description
Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel.
The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.
The Secret RF is consists of ;
- 1) Secret RF main unit (FDA cleared K170325)
- 2) Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
- 3) Secret RF Smartcure applicator
The Secret RF Smartcure Applicator consists of :
- Smartcure handpiece
- Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)
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K Number
K173474Device Name
RetiCapture
Manufacturer
Ilooda Co., Ltd.
Date Cleared
2018-07-27
(260 days)
Product Code
HKI
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
Ilooda Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.
Device Description
RetiCapture is a hand-held digital ophthalmic camera that together with the optics modules used to capture digital images and video of fundus and surrounding area of the human eye. RetiCapture has an LED light source visible white light and infrared light. Light target LED's are used to eye position fixation during imaging. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.
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K Number
K173038Device Name
CuRAS Nd:YAG Laser
Manufacturer
Ilooda Co., Ltd.
Date Cleared
2017-12-01
(64 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Ilooda Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CuRAS Nd; Y AG laser system in indicated for : the incision, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
532nm Wavelength :
- Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Cafe-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength:
- Tattoo removal: dark ink (black, blue and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation.
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkle
Device Description
The CuRAS Nd;YAG laser system is comprised of the following major components:
- 1. The main console unit
- 2. Delivery handpieces
- 3. Footswitch.
- 4. Accessories
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K Number
K170325Device Name
SECRET RF
Manufacturer
Ilooda Co., Ltd.
Date Cleared
2017-06-13
(131 days)
Product Code
GEI, OUH
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Ilooda Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
Device Description
Secret RF's High Frequency(=Radio Frequency) includes the system main body, a bipolar handpiece(Two type) with disposable micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.
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K Number
K160312Device Name
FRAXIS DUO
Manufacturer
ILOODA CO., LTD
Date Cleared
2016-10-28
(266 days)
Product Code
GEX, GEI, OUH
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ILOODA CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
- HF electrosurgical Part : The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Device Description
FRAXIS DUO is a combination of two separate systems: CO2 laser and HF electrosurgical system. The Laser and High Frequency(=Radio frequency) can not be used simultaneously. FRAXIS DUO's CO2 laser includes the system main body, different handpieces(Fractional type, Non-fractional type), footswitch and an LCD Touch screen control panel. FRAXIS DUO's CO2 laser utilize a CO2 RF tube to generate a laser beam with a wavelength of 10,600nm and use different handpiece(Fractional type, Non-fractional type) for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The laser are supplied with different handpieces depending upon the device configuration. FRAXIS DUO's High Frequency(=Radio Frequency) includes the system main body, a Bipolar handpiece equipped with disposable micro-needle electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered using disposable micro-needle electrodes.
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K Number
K151232Device Name
VIKINI Diode Laser System
Manufacturer
ILOODA CO., LTD
Date Cleared
2015-08-06
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ILOODA CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIKINI DIODE LASER SYSTEM is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Device Description
Not Found
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