Hand-held IPL device (JOVS Hair Removal Device) is a personal, light-based, hair reduction device. The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only. Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Hand-held IPL device), which is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel device performance claims.

Therefore, the document does not contain the information requested regarding specific acceptance criteria, a study proving the device meets those criteria, or details about test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details typical for an AI/ML device submission for which these questions would be highly relevant.

The performance data section (Section 7) briefly mentions:

Electrical Safety and Eye Safety: Stating that testing was performed to and passed various IEC standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83). This implies that meeting these standards' requirements for safety would be the acceptance criteria for these aspects. No specific numerical performance figures are given beyond "passed."
Software Verification and Validation: Mentions that software documentation consistent with a moderate level of concern was submitted, and "System validation testing... demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels." This is a high-level statement and does not provide specific performance metrics or studies.
Usability: States that usability testing was performed to and passed IEC 60601-1-6.

In summary, the document addresses safety and basic performance by stating compliance with recognized electrical safety, eye safety, and usability standards, and that software requirements were met and hazards mitigated. However, it does not provide the specific type of detailed performance study data (e.g., sensitivity, specificity, accuracy, or comparative clinical effectiveness metrics) that would typically be described with the types of questions posed in your prompt, particularly related to AI/ML device performance.

This 510(k) submission primarily relies on demonstrating substantial equivalence through comparison of technological characteristics and confirmation of compliance with established safety standards for similar devices, rather than a novel clinical validation study with the metrics you've requested.

Summary

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April 27, 2022

Shenzhen Qianyu Technology Co., Ltd. % Klem Hou RA Manager Guangzhou Tianke Testing Technology Service Co., Ltd. Room 106-1, 1st Floor, Building A, No. 1, Xin'an Road, Yonghe Economic Zone, Huangpu District Guangzhou, Guangdong 510000 China

Re: K220645

Trade/Device Name: Hand-held IPL device (JOVS Hair Removal 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: OHT Dated: March 2, 2022 Received: March 4, 2022

Dear Klem Hou:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220645

Device Name

Hand-held IPL device (JOVS Hair Removal Device)

Indications for Use (Describe)

Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K220645

1. Submitter

Shenzhen Qianyu Technology Co., Ltd.

Room 1002, Building A2, KeXing Science Park, No.15 Keyuan Road, Nanshan District,

Shenzhen, Guangdong Province, China

Post code: 518100

Tel.: +86 158 1380 6593

Klem Hou

RA manager

Tel: +86 178 7557 1727

Email: pharmaklem@outlook.com

2. Device

Name of Device: Hand-held IPL device (JOVS Hair Removal Device)

Model(s): JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG

Common or Usual Name: Light Based Over-The-Counter Hair Removal

Classification Name: Laser surgical instrument for use in general and plastic surgery and in

dermatology

Regulatory Class: II

Product Code: OHT

Regulation Number: 21 CFR 878.4810

3. Predicate device(s)

Manufacturer	Predicate Device	510(k) Number
CyDen Ltd	IPulse SmoothSkin Gold HairRemoval Device	K160968
SHENZHEN JVK MEDICALINSTRUMETS CO., LTD	Hand-held IPL device (JOVSGraphene Hair Removal Device)	K214113

Device description 4.

Hand-held IPL device (JOVS Hair Removal Device) is a personal, light-based, hair reduction device.

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The device contains a Xenon lamp and provides hair reduction by Intense Pulsed Light (IPL) technology and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device is for single-person use only.

Hand-held IPL device (JOVS Hair Removal Device) includes JR5C-E, JR5C-W, JR5C-OG, JR5-E, JR5-W, JR5-OG. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

5. Indications for Use

Hand-held IPL device (JOVS Hair Removal Device) is an over-the-counter device intended for removal of unwanted body and/or facial hair.

6. Comparison of Technological Characteristics with the Predicate Device(s)

Hand-held IPL device (JOVS Hair Removal Device) has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use.

Hand-held IPL device (JOVS Hair Removal Device) is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance:

K160968(Primary Predicate Device), " IPulse SmoothSkin Gold Hair Removal Device ", manufactured by " CyDen Ltd " in Swansea, United Kingdom
K214113, "Hand-held IPL device (JOVS Graphene Hair Removal Device)", manufactured by "SHENZHEN JVK MEDICAL INSTRUMETS CO., LTD " in Guangdong, China

ComparisonElements	Subject Device	Primary PredicateDevice 1(K160968)	Predicate Device 2(K214113)	Remark
Device name	Hand-held IPLdevice (JOVS HairRemoval Device)	IPulse SmoothSkinGold Hair RemovalDevice	Hand-held IPLdevice (JOVS HairGrapheneRemoval Device)	--
Model	JR5C-E, JR5C-W,JR5C-OG, JR5-E,JR5-W, JR5-OG	--	JOC-910-YellowJOC-910-Emerald	--
ComparisonElements	Subject Device	Primary PredicateDevice 1(K160968)	Predicate Device 2(K214113)	Remark
ClassificationName	Laser surgicalinstrument for use ingeneral and plasticsurgery anddermatology	Laser SurgicalInstrument For UseIn General AndPlastic Surgery AndIn Dermatology	Laser surgicalinstrument for use ingeneral and plasticsurgery anddermatology	SE
Product code	OHT	OHT	OHT	SE
Regulationnumber	878.4810	878.4810	878.4810	SE
Class	II	II	II	SE
Prescription orOTC	OTC	OTC	OTC	SE
Indications foruse	Hand-heldIPLdevice (JOVS HairRemoval Device) isan over-the-counterdevice intended forremovalofunwantedbodyand/or facial hair.	TheiPulseSmoothSkin GoldHairRemovalSystem is indicatedfor the removal ofunwanted hair. TheiPulse SmoothSkinGold is alsoindicated for thepermanentreduction in hairregrowth, defined asthe long-term,stable reduction inthe numberof hairs regrowingwhen measured at 6,9 and 12 monthsafter the completionof atreatment regime.	The Hand-held IPLdevice (JOVSGrapheneHairRemoval Device) isan over-the-counterdevice intended forremovalofunwantedbodyand/or facial hair.	SE
Source Energy	Supplied by externaladapter	Supplied byexternal adapter	Supplied by externaladapter	SE
ComparisonElements	Subject Device	Primary PredicateDevice 1(K160968)	Predicate Device 2(K214113)	Remark
Technology	Intense Pulsed Light(IPL)	Intense Pulsed Light(IPL)	Intense Pulsed Light(IPL)	SE
Energymedium	Xenon lamp	Xenon lamp	Xenon lamp	SE
PulsingControl	Finger switch	Finger switch	Finger switch	SE
Deliverydevice	Direct illuminationto tissue	Direct illuminationto tissue	Direct illuminationto tissue	SE
Wavelength	590nm〜1200nm	510-1100nm	590nm〜1200nm	SE
Energy density	1.83~5.14 J/cm2	3-6J/cm2	2.9~5.4 J/cm2	SE
Spot size	3.5cm2	3cm2	3.4cm2	SE
Output energy	6.4~18 J	9.0-18.0J	9.8~18.4 J	SE
Pulse duration	5.5~9.5 ms	2~10ms	5.5~9.5 ms	SE

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7. Performance Data

The following performance data are provided in support of the substantial equivalence determination.

1) Electrical Safety and Eye Safety

Electrical safety and Eye safety testing has been performed to, and passed, the following standards:

≫ IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
A IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical

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Equipment and Medical Electrical Systems Used in the Home Healthcare Environment

IEC 60601-2-83 Medical Electrical Equipment -- Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment

2) Software Verification and Validation

Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications have been met and all software hazards have been mitigated to acceptable risk levels.

3)Usability

Usability testing has been performed to, and passed, the following standards:

A IEC 60601-1-6 Medical electrical equipment -Part 1-6: General requirements for safety -Collateral standard: Usability

Summary

Based on the above performance as documented in this application, the Hand-held IPL device (JOVS Hair Removal Device) is found to have a safety and effectiveness profile that is similar to the predicate device.

8. Conclusions

Based on the comparison of intended use, design, materials and performance, the Hand-held IPL device (JOVS Hair Removal Device) is considered to be substantially equivalent to its predicate device.

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.