IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02

• K Number: K230360
• Device Name: IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
• Manufacturer: Shenzhen Jizhimei Technology Co., Ltd.
• Date Cleared: 2023-04-10 ( 59 days)
• Product Code: OHT
• Regulation Number: 878.4810

Intended Use

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

Device Description

IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. The device 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 and its IPL emission activation is by finger switch. The IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

Predicate Devices

K220645, K221002

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on standard IPL technology, safety testing, and basic software validation. There is no mention of AI, ML, or any related concepts like image processing for analysis or adaptive treatment.

Therapeutic

No
The device is intended for the removal of unwanted hair, which is a cosmetic purpose, not a medical condition or disease that would qualify it as a therapeutic device.

Diagnostic

No

Explanation: The device description clearly states its intended use is for "removal of unwanted body and/or facial hair" for cosmetic purposes, not for diagnosing any medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as an external power adapter, finger switch, light exit, skin sensor, and cooling function, indicating it is a physical device utilizing Intense Pulsed Light technology, not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "removal of unwanted body and/or facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one.
• Mechanism of Action: The device uses Intense Pulsed Light (IPL) to reduce hair growth. This is a physical interaction with the body (specifically hair follicles), not an in vitro test performed on biological samples outside the body.
• Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze biological samples (like blood, urine, tissue) to provide information about a patient's health.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This IPL device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

OHT

Device Description

IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. The device 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 and its IPL emission activation is by finger switch. The IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body and/or facial hair (e.g., face, lips, underarms, bikini lines, arms, legs)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-the-counter, home-use device

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

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

1. Biocompatibility Testing: Evaluation for the body-contacting components was conducted in accordance with ISO 10993-1. Testing performed and passed included ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) and ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization).
2. Electrical Safety and EMC: Testing was performed to, and passed, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83.
3. Eye Safety: Compliance with IEC 62471 Photobiological safety of lamps and lamp systems was evaluated.
4. Software Verification and Validation: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

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

Not Found

Predicate Device(s)

K220645, K221002

Reference Device(s)

Not Found

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

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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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 10, 2023

Shenzhen Jizhimei Technology Co., Ltd. % Riley 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: K230360

Trade/Device Name: IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 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: February 10, 2023 Received: February 10, 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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Colin K. Chen -S

for

Jianting Wang Acting 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

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Indications for Use

510(k) Number (if known) K230360

Device Name IPL Cooling Hair Removal Device Model(s): NBB01, NBB02

Indications for Use (Describe)

The IPL Cooling 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

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

I. Submitter

Shenzhen Jizhimei Technology Co., Ltd. Building A203, Building A/B, Zone B, Gonghe Community, Shajing Street, Baoan District, Shenzhen, China Post code: 518100 Tel.: [phone]

Guo Miaosi Legal representative Tel: [phone] Email: [e-mail]

II. Device

Name of Device: IPL Cooling Hair Removal Device Model(s): NBB01, NBB02 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 Devices

Primary Predicate Device >

Manufacturer	Primary Predicate Device	510(k) Number	Approval Date
Shenzhen Qianyu
Technology Co., Ltd.	Hand-held IPL device (JOVS
Hair Removal Device)	K220645	April 27, 2022

Secondary Predicate Device >

Manufacturer	Predicate Device	510(k) Number	Approval Date
Shenzhen Ulike Smart
Electronics Co.,Ltd	IPL Hair Removal Device,
Model(s): UI04A, UI04B,
UI04C	K221002	June 1, 2022

IV. Device Description

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IPL Cooling Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed two models with the same IPL technology for hair removal, which is model NBB01 and NBB02. The device 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 and its IPL emission activation is by finger switch. The IPL Cooling Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.6cm2 that is suttable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc. The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Cooling Hair Removal Device has the cooling function, which will be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

V. Indications for Use

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

VI. Materials

Component name	Material of Component	Body Contact Category	Contact Duration
IPL Cooling Hair
Removal Device
(Enclosure and
light exit)	PC, ABS	Surface-contacting
device: Intact skin	Less than 24 hours

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".

VII.Comparison of Technological Characteristics With the Predicate Device

The IPL Cooling Hair Removal Device (model: NBB01, NBB02) 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 subject device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Cooling Hair Removal Device may be found substantially equivalent to its predicate devices.

| Comparison

Elements	Subject Device	Primary Predicate Device	Predicate Device	Remark
510(k)
Number	K230360	K220645	K221002	/
Trade name	IPL Cooling
Removal Device	Hand-held IPL device
(JOVS Hair
Removal Device)	IPL Hair Removal
Device, Model(s):
UI04A, UI04B, UI04C	/
Comparison
Elements	Subject Device	Primary Predicate Device	Predicate Device	Remark
Manufacturer	Shenzhen Jizhimei
Technology Co., Ltd.	Shenzhen Qianyu
Technology Co., Ltd.	Shenzhen Ulike Smart
Electronics Co.,Ltd
Regulation
number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Product code	OHT	OHT	OHT	Same
Device
classification	Class II	Class II	Class II	Same
Indication for
use/ Intended
use	The IPL Cooling Hair
Removal Device is an
over-the-counter device
intended for removal of
unwanted body and/or
facial hair.	Hand-held IPL device
(JOVS 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.	Same
Prescription
or OTC	OTC	OTC	OTC	Same
Applicable
skin	Fitzpatrick skin types I-V	Unknown	Fitzpatrick skin types I-V	Same
Source energy	100-240V, 50/60Hz	Unknown	100-240V, 50/60Hz	Same
Power supply	Supplied by external
adapter	Supplied by external
adapter	Supplied by external
adapter	Same
Dimension	NBB01:
47.654.3240 mm
NBB02-MAX:
2357643 mm	Unknown	60.5(W)x38(H)x169.7(L)
mm	Different
Note 1
Sterilization	No	No	No	Same
Wavelength
range	550-1200mm	590nm~1200nm	550-1200mm	Same
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Same
Energy
medium	Xenon Arc Flashlamp	Xenon lamp	Xenon Arc Flashlamp	Same
Energy
density	2~5/cm2 (applicable for
model NBB01)
2~4J/cm2 (applicable for
model NBB02)	1.83~5.14J/cm²	3.03-5.3J/cm²	Similar
Note 2
Comparison
Elements	Subject Device	Primary Predicate Device	Predicate Device	Remark
Output energy	Model NBB01:
8 ~ 17.05J
Model NBB02:
7.14~13.62J	6.4~18 J	10~17.5J	Similar
Note 2
Output
intensity level	NBB01: 5 levels
NBB02: 6 levels	Unknown	5 levels	Similar
Spot size	3.6cm2
(applicable
for
model
NBB01
and
NBB02)	3.5cm2	3.3cm2	Similar
Pulse duration	6.4-7.2ms	5.5~9.5 ms	7-10ms	Similar
Note 3
Pulsing
control	Finger switch	Finger switch	Finger switch	Same
Delivery
device	Direct illumination to
tissue	Direct illumination to tissue	Direct illumination to
tissue	Same
Software/
Firmware/
Microprocess
or Control?	Yes	Yes	Yes	Same
Biocompatibil
ity	ISO10993-5
ISO10993-10	Unknown	ISO10993-5
ISO10993-10	Same
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	IEC 60601-1-2
IEC 60601-1-11
ANSI AAMI ES60601-1
IEC 60601-2-57
IEC 60601-2-83	Same

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Note 1:

Though the dimension is different from the predicate device, this difference is insignificant and do not raise any safety/effectiveness problems.

Note 2:

Though the energy density and the output energy of subject device is a little different from the primary predicate device, the energy density and the output energy of subject device is within the range of the minimum and maximum value of the primary predicate device, and the device complies with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

Note 3:

Though the pulse duration of subject device is different from the primary predicate device, it's basically within the range of the primary predicate device, and the subject device complies with

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IEC IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.

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 Cooling 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

2) Electrical Safety and EMC

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

• ANSI AAMI ES60601-1 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 disturbances -Requirements and tests

• 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.

IX. Conclusions

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