IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

• K Number: K222537
• Device Name: IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
• Manufacturer: Shenzhen Ishine Technology Company Limited
• Date Cleared: 2022-10-14 ( 53 days)
• Product Code: OHT
• Regulation Number: 878.4810

Intended Use

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.

Device Description

IPL Hair Removal Device (Models:skn001,skn005,skn002,RoseSkinCo Lumi),is an overthe-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). 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 and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

Predicate Devices

K213041

Reference Devices

K221002

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI or ML, and the device description focuses on basic sensor technology and user-activated IPL.

Therapeutic

No.
A therapeutic device is typically understood to diagnose, treat, or prevent a disease or condition for the purpose of restoring health or mitigating illness. This device is indicated for hair removal and permanent hair reduction, which are cosmetic purposes and not related to treating a medical disease or condition.

Diagnostic

No

Explanation: The device is an IPL hair removal device indicated for the removal of unwanted hair and reduction in hair regrowth. It is not designed to diagnose any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical device that uses Intense Pulsed Light (IPL) and has hardware components like a power adapter, finger switch, and skin sensor.

IVD (In Vitro Diagnostic)

Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The description clearly states the device uses Intense Pulsed Light (IPL) to remove unwanted hair and reduce hair regrowth. It works on the skin's surface and does not involve analyzing any biological samples.
• Intended Use: The intended use is for hair removal and reduction, not for diagnosing or monitoring any medical condition.

The device is a therapeutic or cosmetic device that uses light energy to achieve its intended purpose, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

OHT

Device Description

IPL Hair Removal Device (Models:skn001,skn005,skn002,RoseSkinCo Lumi),is an overthe-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). 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 and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

IPL Hair Removal Device, models: skn001,skn006 have the same indication for use, performance, structure design and operation, the only deference is their appearance and weight. Model skn002 is not only different in appearance and weight, but the output intensity level is different ( with 6 levels). Model RoseSkinCo Lumi is identical to skn002 and only different in model names.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Intense Pulsed Light

Anatomical Site

multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use; home-use and single-person-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:
   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 -Par t 5: Tests for In Vitro Cytotoxicity
• ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

2. Electrical Safety and EMC:
   Electrical safety and EMC testing was performed to, and passed, as per 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
• ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
• 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 following FDA guidance

• Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016

Key Metrics

Not Found

Predicate Device(s)

K213041

Reference Device(s)

K221002

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 14, 2022

Shenzhen Ishine Technology Company Limited % Yvonne Liu Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 China

Re: K222537

Trade/Device Name: IPL Hair Removal Device, Model(s): skn001,skn005,skn002,RoseSkinCo Lumi 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: August 19, 2022 Received: August 22, 2022

Dear Yvonne Liu:

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,

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) K222537

Device Name IPL Hair Removal Device

Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

Indications for Use (Describe)

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.

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 ISHINE TECHNOLOGY COMPANY LIMITED

Room 213 Building 4,No.45, Makan Road,Makan Community,Xili Sub-District,Nanshan District,Shenzhen,China Post code: 518055 Tel .: [phone] Chaohui An General Manager Tel: [phone] Email: [e-mail]

II. Device

Name of Device: IPL Hair Removal Device Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi 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	Approval Date
Glan Electronics Co.,Ltd	IPL Hair Removal, Model:
OBT-02	K213041	Nov 18, 2021

Reference device:

Manufacturer	Reference 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

IPL Hair Removal Device (Models:skn001,skn005,skn002,RoseSkinCo Lumi),is an overthe-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed

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Light (IPL). 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 and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.

IPL Hair Removal Device, models: skn001,skn006 have the same indication for use, performance, structure design and operation, the only deference is their appearance and weight. Model skn002 is not only different in appearance and weight, but the output intensity level is different ( with 6 levels). Model RoseSkinCo Lumi is identical to skn002 and only different in model names.

V. Indications for Use

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.

VI. Materials

| Component

name	Material of Component	Body Contact Category	Contact Duration
IPL Hair
Removal Device
(Enclosure and
flash window)	ABS, PC	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 Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device 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 device and reference device for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate device and reference device.

IPL Hair Removal Device is compared with the following Predicate Device and Reference Device in terms of intended use, design, material,specifications, and performance:

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| Comparison

Elements	Subject Device	Predicate Device	Reference Device	Remark
510(k)
Number	Pending	K213041	K221002	/
Trade name	IPL Hair Removal Device
(skn001,skn005,skn006,skn
002,RoseSkin Co Lumi)	IPL Hair Removal,
Model:OBT-02	IPL Hair Removal Device
(UI04A, UI04B, UI04C)	/
Manufacturer	SHENZHEN
TECHNOLOGY
COMPANY LIMITED	Glan Electronics Co.,
Limited.	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	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.	The IPL Hair Removal
Device OBT-02 Version
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. The device is
used for adults.	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, only
wording
difference
Prescription
or OTC	OTC	OTC	OTC	Same
	Device design
Source
energy	Supplied by external
adapter	Supplied by external
adapter	Supplied by external
adapter	Same
Power
Supply	100-240V~, 50/60Hz	Unknown	100-240V~, 50/60Hz	Same
Comparison
Elements	Subject Device	Predicate Device	Reference Device	Remark
Dimension	skn001:1348348.5mm
skn005:132.58348mm
skn006:135.58652.5mm
skn002:1348240mm
RoseSkinCo Lumi:
1348240mm	1507545mm(HWD)	60.5(W)x38(H)x169.7(L)
mm	Different
Note 1
Weight	skn001:196g
skn005: 196g
skn006: 210g
skn002: 186g
RoseSkinCo Lumi:186g	220g	Unknown	Different
Note 1
Sterilization	Not required	Not required	Not required	Same
Output specification
Light Source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Same
Energy
medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Same
Wavelength
range	510-1100nm	510-1100nm	550-1200mm	Same
Spot
Size
( cm2 )	3.3 $cm^2$	3.0 $cm^2$	3.3 $cm^2$	Similar
Note 2
Energy
Density	For sk001,skn005,skn006
Level 1: 1.5 J/cm²
Level 2: 1.9J/cm²
Level 3: 2.3J/cm²
Level 4: 2.8J/cm²
Level 5: 3.5J/cm²
For skn002 and
RoseSkinCo Lumi
Level 1: 1.6J/cm²
Level 2: 1.9J/cm²
Level 3: 2.3J/cm²
Level 4: 2.8J/cm²
Level 5: 3.2J/cm²
Level 6: 3.8J/cm²	Level 1: 1.5 J/cm²
Level 2: 1.9 J/cm²
Level 3: 2.6 J/cm²
Level 4: 3.7 J/cm²
Level 5: 4.0 J/cm²	3.03-5.3J/cm²	Similar
Note 3
Comparison
Elements	Subject Device	Predicate Device	Reference Device	Remark
Pulse
duration	6-8ms	3ms	7-10ms	Similar
Note 4
Pulsing
control	Finger switch	Finger switch	Finger switch	Same
Number
of
output
channels	One channel	One channel	Unknown	Same
Output
intensity
level	5 Levels for skn001,skn005,skn006;
6 Levels for skn002 and RoseSkinCo Lumi	5 Levels	5 Levels	Similar
Note 3
Skin Contact
Sensor	Yes	Yes	Unknown	Same
Software/
Firmware/
Microprocess
or Control?	Yes	Yes	Yes	Same
Additional features
Electrical
safety	ANSI AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83	IEC 60601-1-1
IEC 60601-1-2
IEC 60601-2-57	IEC 60601-1-2
IEC 60601-1-11
ANSI AAMI ES60601-1
IEC 60601-2-57
IEC 60601-2-83	Similar
Eye safety	IEC 62471	Unknown	IEC 62471	Same
Biocompatibi
lity	ISO 10993-5
ISO 10993-10	ISO 10993-5
ISO 10993-10	ISO 10993-5
ISO 10993-10	Same

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Note 1:

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

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Note 2:

There is minor difference in spot size between the subject device and the predicate device. The spot size is related to light intensity and since the difference in light intensity is not significant as explained in note 3, so this difference will not raise any safety or effectiveness issue.

Note 3:

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

Note 4:

Though the pulse duration of subject device is a little different from the predicate device, it's similar to the reference device, and the subject device complies with 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 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 -Par t 5: Tests for In Vitro Cytotoxicity

• ISO 10993-10:2010, Biological Evaluation of Medical Devices -Par t 10: Tests for Irritation and Skin Sensitization

2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per 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

• ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)

• 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

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• 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 following 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 device and reference device.