K Number

Device Name

IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9

Manufacturer

Shenzhen Qianyu Technology Co., Ltd.

Date Cleared

2023-09-07

(79 days)

Product Code

OHT

Regulation Number

878.4810

Intended Use

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

Device Description

IPL Hair Removal Device is a personal, light-based, home-use hair reduction device intended to be sold over-the-counter. The device provides hair reduction by using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter (100-240V, 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the light outlet of the device is not in full contact with the skin, the device cannot emit the treatment light pulses. The device includes JP1, JR3, JR9 four models. There is difference in product appearance, physical product dimension, indicator display, spot size and output energy, but their intended use, performance, structure design and operation are basically identical.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K214113, K223618

Reference Devices

K220669

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related concepts like training/test sets, image processing, or specific algorithms. The device description focuses on basic sensor technology and light emission control.

Therapeutic

No
The device is intended for "removal of unwanted body and/or facial hair" for cosmetic purposes, not for treating or preventing disease.

Diagnostic

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for removal of unwanted body and/or facial hair," which is a treatment function, not a diagnostic one. There is no mention of the device being used to identify, diagnose, or monitor a medical condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical device utilizing Intense Pulsed Light (IPL) technology, powered by an external adapter, and includes hardware components like a skin sensor and finger switch. While it mentions software verification and validation, this is for the software controlling the hardware, not a standalone software device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside of the body to diagnose, monitor, or screen for diseases or conditions.
Device Function: The IPL Hair Removal Device works by applying light energy directly to the skin to reduce hair growth. It does not analyze any biological samples taken from the body.
Intended Use: The intended use is for "removal of unwanted body and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
Mechanism of Action: The device uses Intense Pulsed Light (IPL) technology to target hair follicles in vivo (within the living body), not to analyze samples in vitro (in a lab setting).

Therefore, based on its intended use, mechanism of action, and the information provided, this device clearly falls outside the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

OHT

Device Description

The device is only powered by the external power adapter (100-240V, 50/60Hz) and its IPL emission activation is by finger switch. It contains a skin sensor to detect appropriate skin contact, if the light outlet of the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

The device includes JP1, JR3, JR9 four models. There is difference in product appearance, physical product dimension, indicator display, spot size and output energy, but their intended use, performance, structure design and operation are basically identical.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body and/or facial hair

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home-use / Over-The-Counter

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)

Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was 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 September 4, 2020", as recognized by FDA. The following testing was 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
ISO 10993-10: 2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
ISO 10993-23: 2021, Biological evaluation of medical devices Part 23: Tests for irritation

Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the following standards:

IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
IEC 60601-1-11 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
IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

Eye Safety:

IEC 62471 Photobiological safety of lamps and lamp systems

Software Verification and Validation: Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
Usability: The product usability has been evaluated and verified according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued on FEBRUARY 2016.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K214113, K223618

Reference Device(s)

K220669

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 7, 2023

Shenzhen Oianyu Technology Co., Ltd. % Rilev Chen Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China

Re: K231800

Trade/Device Name: IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 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: June 19, 2023 Received: June 20, 2023

Dear Riley Chen:

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.

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,

Tanisha L. Hithe -S Tanisha L. 2023.09.07 Hithe -S 12:21:30 -04'00'

Tanisha Hithe 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

Enclosure

Indications for Use

510(k) Number (if known) K231800

Device Name IPL Hair Removal Device Model(s): JP1, JR3, JR8, JR9

Indications for Use (Describe)

IPL 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 - K231800

"510(k) Summary" as required by 21 CFR Part 807.92.

I. 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: 518057

Guoyang Li Certification Engineer Tel: +86 15099998872 Email: liguoyang(@jovs-beauty.com

II. Device

Name of Device: IPL Hair Removal Device Model(s): JP1, JR3, JR8, JR9 Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation 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

III. Predicate Device

Primary predicate device:

Manufacturer	Predicate Device	510(k) Number
SHENZHEN
MEDICAL
INSTRUMENTS CO., LTD.	JVK
Hand-held IPL device (JOVS
Graphene Hair Removal
Device)	K214113	April 5, 2022

Secondary predicate device:

Manufacturer	Predicate Device	510(k) Number
Shenzhen Ulike Smart
Electronics Co.,Ltd	IPL Hair Removal Device,
Model(s): UI06 PN, UI06 PL,
UI06 JL, UI06 BR, UI06 DB,
UI06 PR, UI06 OG, UI06 RD	K223618	Feb. 28, 2023

Reference device:

Manufacturer	Reference Device	510(k) Number
Shenzhen
Junbobeauty
Technology Co., Ltd.	IPL HAIR REMOVAL
HANDSET, Model: IPL-666	K220669	May 16, 2022

IV. Device Description

V. Indications for Use

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

VI. Materials

Model	Material of Component	Body Contact Category	Contact Duration
JP1	Plastic
JR3	ABS, PC
JR8	ABS, PC, Sapphire, Zinc Alloy,
Epoxy	Surface-contacting
device: Intact skin	Less than 24 hours
JR9	ABS, PC, Sapphire

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".

VII.Comparison of Technological Characteristics With the Predicate Device

The IPL 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 and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.

| Comparison

Elements	Subject Device	Primary Predicate Device	Secondary Predicate Device	Reference Device	Remark
510(k) Number	Pending	K214113	K223618	K220669	/
Trade name	IPL Hair Removal Device
(model: JP1, JR3, JR8, JR9)	Hand-held IPL device
(JOVS Graphene Hair
Removal Device)	IPL Hair Removal Device,
Model(s): UI06 PN, UI06 PL, UI06
JL, UI06 BR, UI06 DB, UI06 PR,
UI06 OG, UI06 RD	IPL HAIR REMOVAL
HANDSET
Model: IPL-666	/
Regulation
number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Product code	OHT	OHT	OHT	OHT	Same
Device
classification	Class II	Class II	Class II	Class II	Same
Indication
for
use/
Intended
use	IPL Hair Removal Device is
an over-the-counter device
intended for removal of
unwanted body and/or facial
hair.	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.	IPL Hair Removal Device is
indicated for the removal of
unwanted hair. The device is also
indicated for the permanent
reduction in hair regrowth, 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.	IPL HAIR REMOVAL
HANDSET is an over the-
counter device intended for
removal of unwanted body
and/or facial hair.	Same
Prescription or
OTC	OTC	OTC	OTC	OTC	Same
Source energy	Supplied by external adapter	Supplied by external adapter	Supplied by external adapter	External Power supply	Same
Power supply	100-240V, 50/60Hz	AC 100-240 V, 50/60 Hz	100~240V, 50/60Hz	100~240V AC Input
12V3A DC Output	Same
Dimension	JP1: 188.15×58×70.6mm
JR3: 159×58×58mm	Unknown	58×34×179mm
(W x H x D)	1248348.5mm	Different
Comparison
Elements	Subject Device	Primary Predicate Device	Secondary Predicate Device	Reference Device	Remark
	JR8: 158.6×58×39mm
JR9: 163.8×78.2×44.6mm
Weight	JP1 & JR3: 265g
JR8: 256g
JR9: 260g	275g	Unknown	186g	Different
Sterilization	Not required	Not required	Not required	Not required	Same
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Same
Energy medium	Xenon Flashlamp	Xenon lamp	Xenon Arc Flashlamp	Xenon Quartz Tube	Same
Wavelength
range	JP1 & JR3: 590-1200nm
JR8 & JR9: 560-1200nm	590nm~1200nm	560-1200nm	470nm ~1100nm	Same
Energy density	JP1: 1.4~2.5J/cm2
JR3: 2.0~4.6J/cm2
JR8: 1.77~5.22J/cm2
JR9: 1.77~5.59J/cm2	2.9~5.4 J/cm2	3~6 J/cm2	1.3~2.49J/cm2	Similar
Spot size	JP1: 1.6cm2
JR3: 3cm2
JR8&JR9: 3.42cm2±0.2cm2	3.4cm2	3.3cm2	3cm2	Similar
Pulse duration	JP1 & JR3: 7.5ms±2ms
JR8 & JR9: 8.2±2ms	5.5~9.5ms	1ms~7ms	11.5~15ms	Similar
Pulsing control	Finger switch	Finger switch	Finger switch	Finger switch	Same
Delivery device	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Same
Output intensity
level	JP1: 3 levels
JR3: 6 levels
JR8: 6 levels
JR9: 5 levels	6 levels	3 levels	5 levels	Same
Software/
Firmware/	Yes	Yes	Yes	Yes	Same
Comparison
Elements	Subject Device	Primary Predicate Device	Secondary Predicate Device	Reference Device	Remark
Microprocessor
Control?
Electrical safety	IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83	IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83	ANSI AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57
IEC 60601-2-83	IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83	Same
Eye safety	IEC 62471	IEC 62471	IEC 62471	IEC 62471	Same
Biocompatibilit
y	ISO 10993-5
ISO 10993-10
ISO 10993-23	ISO 10993-5
ISO 10993-10	ISO 10993-5
ISO 10993-10	ISO 10993-5
ISO 10993-10	Same

VIII. Performance Data

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

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was 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 September 4, 2020", as recognized by FDA. The following testing was 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
ISO 10993-10: 2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
ISO 10993-23: 2021, Biological evaluation of medical devices Part 23: Tests for irritation

2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per the following standards:

IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
IEC 60601-1-11 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
IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

3) Eye Safety

IEC 62471 Photobiological safety of lamps and lamp systems

4) Software Verification and Validation

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

5) Usability

The product usability has been evaluated and verified according to the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices", issued on FEBRUARY 2016.

IX. Conclusions

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate devices.