The Hand-held IPL device (JOVS Graphene 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. The Hand-held IPL device (JOVS Graphene Hair Removal Device) includes JOC-910-Yellow and JOC-910-Emerald. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

AI/ML Overview

The provided text describes the regulatory clearance of a Hand-held IPL device (JOVS Graphene Hair Removal Device) by the FDA, based on its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it detail a comparative effectiveness study involving human readers or standalone AI performance.

The "Performance Data" section (Page 7 & 8) refers to various standard tests conducted for medical devices, such as:

Biocompatibility Testing: ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and skin sensitization).
Electrical Safety and Eye Safety: IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, IEC 60601-2-83.
Software Verification and Validation: Stated as consistent with a moderate level of concern, with system validation testing demonstrating met requirements and mitigated hazards.
Usability: IEC 60601-1-6.

These are standard engineering and safety tests for the device itself, not performance metrics for an AI algorithm's diagnostic capabilities or improvement of human reader performance. The document explicitly states: "Performance data supports that the device is safe and as effective as the predicate device for its intended use." This "performance data" refers to the types of tests listed above, which demonstrate the device's adherence to safety standards and its functional characteristics (e.g., energy density, wavelength) being comparable to legally marketed predicates.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance or its impact on human readers, as the provided document is for a physical IPL device and describes a substantial equivalence determination based on standard device safety and performance characteristics, not an AI algorithm.

The document does not contain the following information, which would be relevant for an AI/ML study focused on diagnostic performance:

A table of acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC).
Reported device performance against those criteria.
Sample sizes for test sets used for AI model evaluation.
Data provenance for AI evaluation (e.g., retrospective/prospective, country of origin).
Number/qualifications of experts for AI ground truth.
Adjudication methods for AI ground truth.
MRMC comparative effectiveness study details (effect size of AI assistance).
Standalone AI performance metrics.
Type of ground truth used for AI (e.g., pathology, outcomes data).
Sample size and ground truth establishment for AI training sets.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 5, 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: K214113

Trade/Device Name: Hand-held IPL device (JOVS Graphene 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

Dear Klem Hou:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 28, 2022. Specifically, FDA is updating this SE Letter to correct an error in the 510(k) summary as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Purva Pandya, OHT4: Office of Surgical and Infection Control Devices, at 240-402-9979 or Purva.Pandya@fda.hhs.gov.

Sincerely,

Purva U. Pandya -S

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

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" in a smaller font below.

March 28, 2022

Re: K214113

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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Purva U. Pandya -S

Enclosure

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Indications for Use

510(k) Number (if known) K214113

Device Name

Hand-held IPL device (JOVS Graphene Hair Removal Device)

Indications for Use (Describe)

The Hand-held IPL device (JOVS Graphene 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

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 Graphene Hair Removal Device)

Model(s): JOC-910-Yellow, JOC-910-Emerald

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
Zhongshan Bisen Plastic ElectronicProducts Co., Ltd.	IPL Hair Removal Device	K212314

4. Device description

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

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K214113

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.

The Hand-held IPL device (JOVS Graphene Hair Removal Device) includes JOC-910-Yellow and JOC-910-Emerald. Their intended use, performance, structure design and operation are basically identical, with the different color appearance.

5. Indications for Use

The Hand-held IPL device (JOVS Graphene 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)

The Hand-held IPL device (JOVS Graphene 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.

The Hand-held IPL device (JOVS Graphene Hair Removal Device) is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance: 1)K160968(Primary Predicate Device), " IPulse SmoothSkin Gold Hair Removal Device ", manufactured by " CyDen Ltd " in Swansea, United Kingdom

2)K212314, " IPL Hair Removal Device ", manufactured by " Zhongshan Bisen Plastic Electronic Products Co., Ltd." in Guangdong, China

ComparisonElements	Subject Device	Primary PredicateDevice 1(K160968)	PredicateDevice 2(K212314)	Remark
Device name	Hand-held IPL device(JOVS Graphene HairRemoval Device)	IPulseGold HairDevice	SmoothSkinRemoval	IPL HairRemoval	--
Model	JOC-910-YellowJOC-910-Emerald	--	BZ-0721	--
ComparisonElements	Subject Device	Primary PredicateDevice 1(K160968)	PredicateDevice 2(K212314)	Remark
RegulationName	Laser surgicalinstrument for use ingeneral and plasticsurgery anddermatology	Laser SurgicalInstrument For Use InGeneral And PlasticSurgery AndIn Dermatology	Laser surgicalinstrument foruse in generaland plasticsurgery anddermatology	SE
Product code	OHT	OHT	OHT	SE
Regulationnumber	878.4810	878.4810	878.4810	SE
Class	II	II	II	SE
Prescriptionor OTC	OTC	OTC	OTC	SE
Indicationsfor use	The Hand-heldIPLdevice(JOVSGrapheneHairRemoval Device) is anover-the-counterdevice intendedforremoval of unwantedbody and/or facial hair.	The iPulse SmoothSkinGold Hair RemovalSystem is indicated forthe removal ofunwanted hair. TheiPulse SmoothSkinGold is also indicatedfor the permanentreduction in hairregrowth, defined asthe long-term, stablereduction in the numberof hairs regrowingwhen measured at 6, 9and 12 months after thecompletion of atreatment regime.	The IPL HairRemovalDevice is anover-the-counter deviceintended forremoval ofunwanted bodyand/or facialhair.	SE
SourceEnergy	Supplied by externaladapter	Supplied by externaladapter	Supplied byexternal adapter	SE
Technology	Intense Pulsed Light(IPL)	Intense Pulsed Light(IPL)	Intense PulsedLight (IPL)	SE
ComparisonElements	Subject Device	Primary PredicateDevice 1(K160968)	PredicateDevice 2(K212314)	Remark
Energymedium	Xenon lamp	Xenon lamp	Xenon lamp	SE
PulsingControl	Finger switch	Finger switch	Finger switch	SE
Deliverydevice	Direct illumination totissue	Direct illumination totissue	Directillumination totissue	SE
Wavelength	590nm - 1200nm	510 - 1100nm	510nm - 1100nm	SE
Energydensity	2.9 - 5.4 J/cm2	3 - 6 J/cm2	1.5 - 3.0 J/cm2	SE
Spot size	3.4 cm2	3 cm2	4 cm2	SE
Outputenergy	9.8 - 18.4 J	9.0 - 18.0J	6.0 - 11.8 J	SE
Pulseduration	5.5 - 9.5 ms	2 - 10 ms	10.4 ms	SE

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7. Performance Data

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

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the Hand-held IPL device (JOVS Graphene Hair Removal Device) has been conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The testing has been performed to, and passed, including:

ISO 10993-5:2009, Biological Evaluation of Medical Devices -Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010, Biological Evaluation of Medical Devices -Part 10: Tests for Irritation and Skin Sensitization

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2) 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
A 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 Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
A IEC 60601-2-83 Medical Electrical Equipment - Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment

4) 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.

5)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

Summarv

Based on the above performance as documented in this application, the Hand-held IPL device (JOVS Graphene 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 Graphene 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.