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..

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Slimming Treatment Device" (models HONKON-Slimming I+ and HONKON-Slimming III+). It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

The document does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (e.g., reduction in cellulite or thigh circumference). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technical specifications, safety, and regulatory compliance.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds for clinical performance but rather as demonstrating substantial equivalence to the predicate devices across various technical and safety parameters. The "Reported Device Performance" in this context refers to the device's technical specifications and the results of non-clinical safety tests.

Item	Acceptance Criteria (Demonstrates SE to Predicate)	Reported Device Performance (Proposed Device)
Intended Use	Similar indications to predicate devices: 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 temporary reduction of thigh circumferences.	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 thigh circumferences.
Regulatory Information	Classification (Class II), Product Code (NUV, ISA), Regulation Number (21 CFR 878.4810) are substantially equivalent.	Classification: II; Product Code: NUV, ISA; Regulation Number: 21 CFR 878.4810
RF Output Energy	The device's RF output energy is considered safe and effective, and performs as well as the predicate device based on non-clinical tests (IEC 60601-2-2). (Predicate devices have up to 50W and up to 150W respectively.)	40-400W
RF Output Frequency	The device's RF output frequency is substantially equivalent to predicate devices (Predicate 1: 0.8 MHz, 1.7 MHz, 2.45 MHz; Predicate 2: N.A.).	1MHz
Max. RF output energy density	The device's max RF output energy density is substantially equivalent to predicate devices (Predicate 1: 78.125W/cm2, 4.76W/cm2, 33.33W/cm2; Predicate 2: 115.38W/cm2, 6.67W/cm2, 12 W/cm2, 9.38W/cm2).	XF-I+:12.14W/cm²; XF-VII+:27W/cm²
Infrared energy	The device's infrared energy is considered safe and effective, and performs as well as the predicate device based on non-clinical tests (IEC 60601-1) for the risk of heat. (Predicate 1: N.A.; Predicate 2: Up to 3.3W).	XF-I+ & XF-VII+: I: 5W II: 7W III: 8W IV: 9W V: 10W
Infrared wavelengths	The device's infrared wavelengths are substantially equivalent (Predicate 1: N.A.; Predicate 2: 850nm).	700-2000nm
Max. IR output energy density	The device's max IR output energy density is substantially equivalent (Predicate 1: /; Predicate 2: 2.54W/cm², 0.44W/cm², 0.26W/cm², 0.21W/cm²).	XF-I+:0.30W/cm²; XF-VII+:0.67W/cm²
Vacuum	The device's vacuum mechanism is substantially equivalent (both predicates use "Pulsed").	Pulsed (-0.08Mpa -- -0.01Mpa)
Mechanical Massage	The device's mechanical massage feature is substantially equivalent (Predicate 1: Yes; Predicate 2: N.A.).	Yes
Treatment Area	Differences in treatment area size are not considered to affect safety and effectiveness.	XF-I+: 3294 mm²; XF-VII+: 1482mm²
Electrical Safety	Compliance with IEC 60601-1 (all devices).	The proposed devices were tested to demonstrated to comply with IEC 60601-1.
EMC	Compliance with IEC 60601-1-2 (all devices).	The proposed devices were tested to demonstrated to comply with IEC 60601-1-2.
Biocompatibility	No toxicity (ISO 10993-5), No irritation (ISO 10993-10), No sensitization (ISO 10993-10) for patient contact materials, demonstrably equivalent to predicate devices.	Cytotoxicity: No toxicity (ISO 10993-5); Irritation: Applied sample did not induce irritation to skin. (ISO 10993-10); Sensitization: The test article showed no signification evidence of causing skin sensitization in the guinea pig. (ISO 10993-10)

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set sample size or data provenance (country, retrospective/prospective) for clinical effectiveness. The "tests" mentioned are non-clinical (electrical safety, EMC, biocompatibility) and comparisons to existing predicate device specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical study or test set with expert-established ground truth was performed for this submission. The "ground truth" for the substantial equivalence claim relies on regulatory standards and the specifications of the predicate devices.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring adjudication was performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical therapeutic device, not an AI-assisted diagnostic or interpretive tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical therapeutic device, not an algorithm. Its operation involves human application.

7. The type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" is largely:

Regulatory Standards: Compliance with established international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-5, -10) for safety and performance.
Predicate Device Specifications: The accepted safety and effectiveness profiles of the legally marketed predicate devices (Reaction™ System K090221 and VelaShape K122579). The proposed device's specifications are compared to these predicates to demonstrate similarity.

8. The sample size for the training set

Not applicable. As no clinical study was conducted. There is no "training set" in the context of device efficacy for this 510(k) submission.

9. How the ground truth for the training set was established

Not applicable, as no training set was used or described.

Summary

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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

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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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161892

Device Name

Slimming Treatment Device

Indications for Use (Describe)

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.

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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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

1. Date of Preparation: 03/01/2017
1. 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

1. Designated Submission Correspondent
  Mr. Ray Wang

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

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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:

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glycerol.

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)]

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

ITEM	Proposed DeviceHONKON-Slimming I+HONKON-SlimmingIII+	Predicate DeviceReactionTM system(K090221)	Predicate DeviceVelaShape(K122579)	Remark
	ProductCode	NUV、ISA	NUV、ISA	NUV
RegulationNo.	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	SE
Class	II	II	II	SE
IntendedUse	The HONKON-SlimmingI+/HONKON-SlimmingIII+ are indicated for therelief of minor muscleaches and pain, relief ofmuscle spasm, temporaryimprovement of localblood circulation,temporary reduction inthe appearance ofcellulite, and fortemporary reduction ofthighs circumferences.	The ReactionTM system isintended for the treatmentof the following medicalconditions, using theB-contour and F-contourapplicators fordelivering non thermal RFcombined with massage:- relief of minor muscleaches and pain, relief ofmuscle spasm,temporary improvement.Of local bloodcirculation,and- temporary reduction inthe appearance of cellulite.Using the ST applicator fordelivering RF, theReactionTM system isintended for the treatmentof relief of minor muscleaches and pain.reliefof.muscle spasm,temporary improvement oflocal blood circulation.	The VelaShape isindicated for therelief of minormuscle aches andpain, relief ofmuscle spasm,temporaryimprovement oflocal bloodcirculation,temporary reductionin the appearance ofcellulite, and fortemporary reductionof thighscircumferences.	SE
ITEM	Proposed DeviceHONKON-SlimmingI+HONKON-SlimmingIII+	Predicate DeviceReaction™ system(K090221)	Predicate DeviceVelaShape(K122579)	Remark
RF OutputEnergy	40-400W	Up to 50w	Up to 150W	Discussion(a)
RF OutputFrequency	1MHz	0.8 MHz, 1.7 MHz,2.45 MHz	N.A	SE
Max.RF outputenergy density	XF-I+:12.14W/cm2XF-VII+:27W/cm2	78.125W/cm24.76W/cm233.33W/cm2	115.38W/cm26.67W/cm212 W/cm29.38W/cm2	SE
Infrared energy	XF-I+ & XF-VII+:I: 5W II: 7W III: 8WIV : 9W V :10W	N.A	Up to 3.3W	Discussion(b)
Infraredwavelengths	700-2000nm	N.A.	850nm	SE
Max. IR outputenergy density	XF-I+:0.30W/cm2XF-VII+:0.67W/cm2	/	2.54W/cm20.44W/cm20.26W/cm20.21W/cm2	SE
Vacuum	Pulsed(-0.08Mpa -- -0.01Mpa)	Pulsed	Pulsed	SE
MechanicalMassage	Yes	Yes	N.A.	SE
Treatment Area	XF-I+: 3294 mm²XF-VII+: 1482mm²	64 mm²1050 mm²150 mm²	VContourApplicator:Small CoverMedium CoverLarge Cover:130 mm²750 mm²1250 mm²VSmoothApplicator:1600 mm²	Discussion(c)
Weight	48KG	17kg. - desktop19 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 DeviceHONKON-Slimming I+HONKON-SlimmingIII+	Predicate DeviceReactionTM system(K090221)	Predicate DeviceVelaShape (K122579)	Remark
Powersupply	110V, 60HZ	90-264 VAC; 50/60 Hz;Single Phase	110VA;50Hz; single phase	SE
ElectricalSafety	The proposed devices weretested to demonstrated tocomply with IEC 60601-1	The proposed deviceswere tested todemonstrated to complywith IEC 60601-1	The proposed deviceswere tested todemonstrated tocomply with IEC60601-1	SE
EMC	The proposed devices weretested to demonstrated tocomply with IEC 60601-1-2	The proposed deviceswere tested todemonstrated to complywith IEC 60601-1-2	The proposed deviceswere tested todemonstrated tocomply with IEC60601-1-2	SE
PatientContactMaterial	HandpieceSuction roller	HandpieceSuction roller	HandpieceSuction roller	SE
Biocompatibility
Cytotoxicity	No toxicity(ISO 10993-5)	No toxicity (ISO 10993-5)	No toxicity (ISO10993-5)	SE
Irritation	Applied sample did notinduce irritation to skin.(ISO 10993-10)	Applied sample did notinduce irritation to skin.(ISO 10993-10)	Applied sample didnot induce irritation toskin. (ISO 10993-10)	SE
Sensitization	The test article showedno signification evidenceof causing skinsensitization in theguinea pig .(ISO10993-10)	The test article showed nosignification evidence ofcausing skin sensitizationin the guinea pig .(ISO10993-10)	The test articleshowed nosignification evidenceof causing skinsensitization in theguinea pig .(ISO10993-10)	SE

Table 1 General Comparison

Table 2 Performance Comparison

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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.

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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.

Regulation Number and Section

§ 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.