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510(k) Data Aggregation
K Number
K161892Device Name
Slimming Treatment Device
Manufacturer
BEIJING HONKON TECHNOLOGIES CO., LTD
Date Cleared
2017-03-02
(234 days)
Product Code
NUV, ISA
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING HONKON TECHNOLOGIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
Device Description
The HONKON-Slimming I+ and HONKON-Slimming III+ are the non-invasive body shaping product to combine four different technologies including IR (infrared), Bi-Polar RF (radio-frequency) and mechanical tissue manipulation using pulsed vacuum and massage rollers. The combination of the IR and vacuum coupled RF technologies causes deep heating of the connective tissue including the fibrous septae which in turn promotes an increase in local cellular reduction. The additional mechanical tissue manipulation of the device causes an immediate increase in circulation and lymphatic drainage, both essential components for healthy skin structure.
The HONKON-Slimming I+ and HONKON-Slimming III+ can output infrared light with wavelength 700-2000nm, the infrared light can penetrate whole skin tissue. The infrared light has the effect to expand blood vessels, temporary improvement of local blood circulation; At the same time, this spectrum has a good efficacy for temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..
The HONKON-Slimming I+ and HONKON-Slimming III+ can output 1MHz frequency, produce RF energy from X, Y and Z directions in the subcutaneous tissue. Temperature of skin tissues becomes higher, Enzyme activity was enhanced so that fat cells can be fully released within the triglyceride; Triglycerides in the fat under the action of enzymes, cracking into fatty acids and glycerol.
Massage rollers has obvious mechanical compression to skin tissues. Meanwhile, deep negative pressure gives skin and muscles full relaxation and rest. Maximum 8kg negative pressure can absorb all skin tissues into the gap between the bipolar RF tips, ensure RF energy can reach fat layers.
Based on this,the HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..
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K Number
K131838Device Name
DIODE LASER FOR HIAR REMOVAL
Manufacturer
BEIJING HONKON TECHNOLOGIES CO., LTD
Date Cleared
2014-04-24
(308 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING HONKON TECHNOLOGIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The diode laser for hair removal is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
Device Description
The diode laser for hair removal is generally included components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. Its models are 808CL, 808CM, 808CH, 808EH, 808BL, 808BM, 808BH, 808FH, 808HGG and 808DH. Theirs differences are between the size of device which is described in the table below:
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K Number
K131837Device Name
CO2 FRACTIONAL LASER
Manufacturer
BEIJING HONKON TECHNOLOGIES CO., LTD
Date Cleared
2014-01-22
(216 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING HONKON TECHNOLOGIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CO2 Laser (10600nm) is indicated for use in dermatological procedures requiring ablation, resurfacing and coagulation of soft tissue.
Device Description
The CO2 Laser consists of semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. The CO2 Laser produces a beam of coherent infrared light with 10600nm wavelength. The CO2 laser comprises five models: YILIYA-10600AH, YILIYA-10600AL, YILIYA-10600CH, Aeslight-10600EH, Aeslight-Ultra peel; their technical parameters and functions are the same, the only difference is their appearances and sizes.
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K Number
K131857Device Name
Q-SWITCHED ND:YAG LASER
Manufacturer
BEIJING HONKON TECHNOLOGIES CO., LTD
Date Cleared
2014-01-16
(206 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING HONKON TECHNOLOGIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1064 nm wavelength: Tattoo Removal (Dark Ink, Black & Blue ) Ota's nevus
532 nm wavelength: Tattoo Removal (Light Ink, Red, Sky Blue and Green) Treatment of Pigmented Lesions Solar Lentiginos Senile Lentiginos
Device Description
The proposed device includes three models as YILIYA- 1064QCH, YILIYA- 1064QCL and Aeslight-1064QEH, the differences between three models described in the subsection 5 specification. The proposed device is the laser system with modularization and multi-wavelength, includes the waveform as 1064 nm and 532 nm. The proposed device consisted by control system, power supplier, cooling system, laser generator, articulated arm and foot switch.
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K Number
K131859Device Name
MULTIFUNCTIONAL SERIES
Manufacturer
BEIJING HONKON TECHNOLOGIES CO., LTD
Date Cleared
2013-10-18
(116 days)
Product Code
ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BEIJING HONKON TECHNOLOGIES CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic and cosmetic applications in hair removal, moderate inflammatory acne vulgaris, and benign cutaneous vascular lesions.
Device Description
The Multifunctional Series device are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 530nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores" thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL. Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penctration without using excessive energy levels and enables targeting of specific chromophores. Based on this, The Multifunctional Series device (inclusive of the handpiece used to deliver pulsed-light energy) are indicated for use in surgical, aesthetic applications in hair removal, acne, and blood vessel lesions. The proposed device includes four models as Aeslight-S3D, HONKON-S3C. HONKON-M40e+ and HONKON-M80e+.
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