(234 days)
Not Found
No
The device description focuses on the combination of physical technologies (IR, RF, vacuum, massage rollers) and their direct effects on tissue. There is no mention of any computational or algorithmic components that would suggest AI/ML.
Yes
The device is indicated for medical purposes such as the relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation, which are therapeutic in nature.
No
The device is indicated for therapeutic purposes such as pain relief, improved blood circulation, and cosmetic changes, not for diagnosing conditions.
No
The device description clearly outlines a physical device that utilizes multiple hardware technologies (IR, Bi-Polar RF, pulsed vacuum, massage rollers) to achieve its intended use. There is no indication that the device is solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The HONKON-Slimming I+/HONKON-Slimming III+ is a non-invasive body shaping device that uses physical methods (IR, RF, vacuum, massage) applied externally to the body. Its intended uses are for the relief of muscle aches and pain, muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite and thigh circumference.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens from the patient. The device interacts directly with the body's tissues externally.
Therefore, based on the provided information, the HONKON-Slimming I+/HONKON-Slimming III+ falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
NUV, ISA
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..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
a)IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
b)IEC 60601-1:2005/A1:2012. Medical electrical equipment - Part 1: General reguirements for basic safety and essential performance
c)IEC60601-2-2:2009+C1:2014,Medical Electrical Equipment - Part 2-2: Particular Requirements for The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories [Including: Technical Corrigendum 1 (2014)]
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Beijing Honkon Technologies Co., Ltd % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. LiYuan Town, TongZhou District Beijing, 101121 CN
Re: K161892
Trade/Device Name: Slimming Treatment Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: NUV, ISA Dated: January 18, 2017 Received: January 23, 2017
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Slimming Treatment Device
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K161892
-
- Date of Preparation: 03/01/2017
-
- Sponsor Identification
BEIJING HONKON TECHNOLOGIES CO., LTD
72 building, 16#Huanke middle road, Golden bridge scientific and technological industry base Tongzhou Yard, Zhongguan village technological Yard, Tongzhou district, Beijing, China.
Establishment Registration Number: 3009488834
Contact Person: Li Yanzhe Position: Registration Manager Tel: +86 10 56370050 ext. 607 Fax: +86 10 56370076 Email:small@honkonlaser.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe Technology Service Co., Ltd.
5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Slimming Treatment Device Common Name: Massager, Vacuum, Light Induced Heating. Model(s): HONKON-Slimming I+、HONKON-Slimming III+
Regulatory Information: Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Classification: II; Product Code: NUV、ISA: Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Intended Use Statement:
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
5
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..
- న. Identification of Predicate Device(s)
Predicate Device I : 510(k) Number: K090221 Predicate Device Name: Reaction™ System Manufacturer: Viora Ltd.
Predicate Device II : 510(k) Number: K122579 Predicate Device Name: VelaShape Manufacturer: Syneron Medical Ltd.
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
a)IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.
b)IEC 60601-1:2005/A1:2012. Medical electrical equipment - Part 1: General reguirements for basic safety and essential performance
c)IEC60601-2-2:2009+C1:2014,Medical Electrical Equipment - Part 2-2: Particular Requirements for The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories [Including: Technical Corrigendum 1 (2014)]
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
6
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device
HONKON-Slimming I+
HONKON-SlimmingIII+ | Predicate Device
ReactionTM system
(K090221) | Predicate Device
VelaShape
(K122579) | Remark |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| | Product
Code | NUV、ISA | NUV、ISA | NUV |
| Regulation
No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | II | SE |
| 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. | The ReactionTM system is
intended for the treatment
of the following medical
conditions, using the
B-contour and F-contour
applicators for
delivering non thermal RF
combined with massage:
- relief of minor muscle
aches and pain, relief of
muscle spasm,
temporary improvement.
Of local blood
circulation,and - temporary reduction in
the appearance of cellulite.
Using the ST applicator for
delivering RF, the
ReactionTM system is
intended for the treatment
of relief of minor muscle
aches and pain.relief
of.muscle spasm,
temporary improvement of
local blood circulation. | The VelaShape is
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. | SE |
| ITEM | Proposed Device
HONKON-SlimmingI+
HONKON-SlimmingIII+ | Predicate Device
Reaction™ system
(K090221) | Predicate Device
VelaShape
(K122579) | Remark |
| RF Output
Energy | 40-400W | Up to 50w | Up to 150W | Discussion
(a) |
| RF Output
Frequency | 1MHz | 0.8 MHz, 1.7 MHz,
2.45 MHz | N.A | SE |
| Max.
RF output
energy density | XF-I+:12.14W/cm2
XF-VII+:27W/cm2 | 78.125W/cm2
4.76W/cm2
33.33W/cm2 | 115.38W/cm2
6.67W/cm2
12 W/cm2
9.38W/cm2 | SE |
| Infrared energy | XF-I+ & XF-VII+:
I: 5W II: 7W III: 8W
IV : 9W V :10W | N.A | Up to 3.3W | Discussion
(b) |
| Infrared
wavelengths | 700-2000nm | N.A. | 850nm | SE |
| Max. IR output
energy density | XF-I+:0.30W/cm2
XF-VII+:0.67W/cm2 | / | 2.54W/cm2
0.44W/cm2
0.26W/cm2
0.21W/cm2 | SE |
| Vacuum | Pulsed
(-0.08Mpa -- -0.01Mpa) | Pulsed | Pulsed | SE |
| Mechanical
Massage | Yes | Yes | N.A. | SE |
| Treatment Area | XF-I+: 3294 mm²
XF-VII+: 1482mm² | 64 mm²
1050 mm²
150 mm² | VContour
Applicator:
Small Cover
Medium Cover
Large Cover:
130 mm²
750 mm²
1250 mm²
VSmooth
Applicator:
1600 mm² | Discussion
(c) |
| Weight | 48KG | 17kg. - desktop
19 kg. - wheel base | 20kg / 44lbs | Discussion
(d) |
| Size(mm)
LWH | 434mm * 531mm 1354mm
(Slimming I+)
531mm * 441mm 1716mm
(Slimming III+) | 400350 450 | 380* 490 *1320 | Discussion
(e) |
| ITEM | Proposed Device
HONKON-Slimming I+
HONKON-SlimmingIII+ | Predicate Device
ReactionTM system
(K090221) | Predicate Device
VelaShape (K122579) | Remark |
| Power
supply | 110V, 60HZ | 90-264 VAC; 50/60 Hz;
Single Phase | 110VA;
50Hz; single phase | SE |
| Electrical
Safety | The proposed devices were
tested to demonstrated to
comply with IEC 60601-1 | The proposed devices
were tested to
demonstrated to comply
with IEC 60601-1 | The proposed devices
were tested to
demonstrated to
comply with IEC
60601-1 | SE |
| EMC | The proposed devices were
tested to demonstrated to
comply with IEC 60601-1-2 | The proposed devices
were tested to
demonstrated to comply
with IEC 60601-1-2 | The proposed devices
were tested to
demonstrated to
comply with IEC
60601-1-2 | SE |
| Patient
Contact
Material | Handpiece
Suction roller | Handpiece
Suction roller | Handpiece
Suction roller | SE |
| Biocompatibility | | | | |
| Cytotoxicity | No toxicity
(ISO 10993-5) | No toxicity (ISO 10993-5) | No toxicity (ISO
10993-5) | SE |
| Irritation | Applied sample did not
induce irritation to skin.
(ISO 10993-10) | Applied sample did not
induce irritation to skin.
(ISO 10993-10) | Applied sample did
not induce irritation to
skin. (ISO 10993-10) | SE |
| Sensitization | The test article showed
no signification evidence
of causing skin
sensitization in the
guinea pig .(ISO
10993-10) | The test article showed no
signification evidence of
causing skin sensitization
in the guinea pig .(ISO
10993-10) | The test article
showed no
signification evidence
of causing skin
sensitization in the
guinea pig .(ISO
10993-10) | SE |
Table 1 General Comparison
Table 2 Performance Comparison
7
8
Table 3 Safety Comparison
Discussion:
The proposed device has the following differences with the predicate device:
- a. RF Output Energy, base on the nonclinical tests (IEC 60601-2-2) performed, the proposed device is as safe, as effective, and performs as well as the predicated device.
- b. Infrared energy, base on the nonclinical tests (IEC 60601-1) performed for the risk of heat, the proposed device is as safe, as effective, and performs as well as the predicated device.
9
- Treatment Area, which only affect the treatment area's size, no concerned with safety and effective, c. the proposed device is as safe, as effective, and performs as well as the predicated device.
- Weight, base on the nonclinical tests (IEC 60601-1) performed for the risk of mechanical, the d. proposed device is as safe, as effective, and performs as well as the predicated device.
- Size, base on the nonclinical tests (IEC 60601-1) performed for the risk of mechanical, the proposed e. device is as safe, as effective, and performs as well as the predicated device.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.