K Number
K232183
Device Name
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
Date Cleared
2023-09-22

(60 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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:T1, T2, T3, T7, T10),is an over-the-counter, home-use and singleperson-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. There are four function modes including skin, face,body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face,underarm,body and bikini for T2 and T10. There are five levels for each mode. The device 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:T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension , weight , number of keys and function modes, spot size and energy density . The five models are in two colors, one set is in white and the other set is in green.
More Information

No
The device description and performance studies do not mention any AI or ML components; the functionality described is based on standard IPL technology and a skin sensor.

No.
A therapeutic device is typically used to treat a disease or medical condition, alleviate symptoms, or restore normal function. This device is indicated for hair removal and permanent reduction in hair regrowth, which is a cosmetic application, not a medical treatment for a disease.

No

The device is an IPL hair removal device, indicated for the removal and permanent reduction of unwanted hair, which is a treatment function, not a diagnostic one.

No

The device description clearly states it is an Intense Pulsed Light (IPL) device that works below the skin's surface and involves hardware components like an external power adapter, finger switch, flash window, and skin sensor. While it mentions software verification and validation, it is not solely software.

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 IPL Hair Removal Device works by applying Intense Pulsed Light to the skin to reduce hair growth. It does not analyze any biological samples from the body.
  • Intended Use: The intended use is for the removal and permanent reduction of unwanted hair, which is a cosmetic or aesthetic purpose, not a diagnostic one.

The device is a medical device, but it falls under a different classification than IVDs.

N/A

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:T1, T2, T3, T7, T10),is an over-the-counter, home-use and singleperson-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. There are four function modes including skin, face,body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face,underarm,body and bikini for T2 and T10. There are five levels for each mode. The device 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:T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension , weight , number of keys and function modes, spot size and energy density . The five models are in two colors, one set is in white and the other set is in green.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Home-use, single-person-use, Over-The-Counter Use

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

  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
  1. 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 60601-1-11 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
  1. Eye Safety:
  • IEC 62471 Photobiological safety of lamps and lamp systems
  1. 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.

  2. 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)

K222537

Reference Device(s)

K221001

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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, with the letters "FDA" in a blue square. Underneath the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 22, 2023

Shenzhen Koli Technology Co.,Ltd % Yvonne Liu 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: K232183

Trade/Device Name: IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 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: July 24, 2023 Received: July 24, 2023

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

1

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. 2023.09.22 Hithe -S 14:53:36 -04'00'

Tanisha Hithe, MS, MHS 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

2

Indications for Use

510(k) Number (if known) K232183

Device Name IPL Hair Removal Device Model(s): T1, T2, T3, T7, T10

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)

Registration Use (Part 34 CFR 301 Subpart D)
On-The-Spot-Use (34 CFR 301 Subpart C)

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary K232183

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

I. Submitter

Shenzhen Koli Technology Co.,Ltd Floor 4, No.145-1 Furui Road, Xintian Community, Fuhai Street, Bao'an District, Shenzhen, China Post code: 518103 Tel.: +86 15818667227 Fu Qizhen General Manager Tel: +86 15818667227 Email: fuqizhen1983@163.com

II. Device

Name of Device: IPL Hair Removal Device Model(s): T1, T2, T3, T7, T10 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 and reference device

Predicate device:

ManufacturerPredicate Device510(k) NumberApproval Date
Shenzhen Ishine Technology
Company LimitedIPL Hair Removal Device,
Model(s):
skn001,skn005,skn006,skn002,
RoseSkinCo LumiK222537Oct 14,2022

Reference device:

ManufacturerReference Device510(k) NumberApproval Date
Shenzhen Beauty Every
Moment intelligent electric
Co.,LtdIPL Home Use Hair Removal
Device, Models: D-1198, D-
1185, D-1186, D-1189, D-
1197K221001May 12, 2022

4

IV. Device Description

IPL Hair Removal Device (Models:T1, T2, T3, T7, T10),is an over-the-counter, home-use and singleperson-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. There are four function modes including skin, face,body and bikini for T1 and T7, but only body mode for T3, and five modes including skin, face,underarm,body and bikini for T2 and T10. There are five levels for each mode. The device 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:T1, T2, T3, T7, T10 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, dimension , weight , number of keys and function modes, spot size and energy density . The five models are in two colors, one set is in white and the other set is in green.

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

nameMaterial of ComponentBody Contact CategoryContact Duration
IPL Hair
Removal Device
(Enclosure and
flash window)ABS, PC,POMSurface-contacting
device: Intact skinLess 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:

5

| Comparison

ElementsSubject DevicePredicate DeviceReference DeviceRemark
510(k)
NumberPendingK222537K221001/
Trade nameIPL Hair Removal Device
T1,T2,T3,T7,T10IPL Hair Removal Device
(skn001,skn005,skn006,skn002,RoseSkin Co Lumi)IPL Home Use Hair
Removal Device,
Models: D-1198, D-
1185, D-1186, D-1189,
D-1197/
ManufacturerShenzhen Koli Technology
Co.,LtdSHENZHEN
TECHNOLOGY
COMPANY LIMITEDShenzhen Beauty Every
Moment intelligent /
electric Co.,Ltd/
Regulation
number21 CFR 878.481021 CFR 878.481021 CFR 878.4810Same
Product codeOHTOHTOHTSame
Device
classificationClass IIClass IIClass IISame
Indication for
use/ Intended
useIPL 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 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 Home Use Hair
Removal Device is an
over-the counter device
intended for removal of
unwanted body and /or
facial hairSame
Prescription
or OTCOTCOTCOTCSame
Source
energySupplied by external
adapterSupplied by external
adapterSupplied by external
adapterSame
Power
Supply100-240V~, 50/60Hz100-240V~, 50/60HzUnknownSame
DimensionT1: 176 x 62 x 35mm
T2: 171 x 64 x 34mm
T3: 214 x 63 x 64mm
T7: 174 x 63 x 36mmskn001:1348348.5mm
skn005:132.58348mm
skn006:135.58652.5mm
skn002:1348240mmUnknownDifferent
Comparison
ElementsSubject DevicePredicate DeviceReference DeviceRemark
T10: 171 x 64 x 35mmRoseSkinCo
1348240mmLumi:
WeightT1: 200g
T2: 296g
T3: 200g
T7: 216g
T10: 216gskn001:196g
skn005: 196g
skn006: 210g
skn002: 186g
RoseSkinCo Lumi:186gUnknownDifferent
SterilizationNot requiredNot requiredNot requiredSame
Light SourceIntense Pulsed LightIntense Pulsed LightIntense Pulsed LightSame
Energy
mediumXenon Arc FlashlampXenon Arc FlashlampXenon Arc FlashlampSame
Wavelength
range510-1100nm510-1100nm550-1100nmSame
Spot
Size
( cm² )T1: $3.0 \pm 0.25cm^2$
T2: $3.9 \pm 0.25cm^2$
T3: $3.2 \pm 0.25cm^2$
T7: $3.0 \pm 0.25cm^2$
T10: $3.9 \pm 0.25cm^2$$3.3cm^2$D-1198: $2.7 cm^2$
D-1185: $2.7 cm^2$
D-1186: $3.0 cm^2$
D-1189: $3.0 cm^2$
D-1197: $3.4 cm^2$Similar
Energy
Density
(±20%)T1,T7: 1.33~3.00 J/cm²
T3: 1.25-2.81 J/cm²
T2,T10: 1.03~ 3.08 J/cm²For 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/cm²2.0~4.3 J/cm²Similar
Pulse
duration4-12ms6-8ms5-12 msSimilar
Comparison
ElementsSubject DevicePredicate DeviceReference DeviceRemark
Pulsing
controlFinger switchFinger switchFinger switchSame
Number
of
output
channelsOne channelOne channelOne channelSame
Output
intensity
level5 LevelsLevels
5
for
skn001,skn005,skn006;
6
Levels for skn002
and
RoseSkinCo LumiUnknownSimilar
Skin Contact
SensorYesYesYesSame
Software/
Firmware/
Microprocess
or Control?YesYesYesSame
Electrical
safetyANSI AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83ANSI AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83IEC 60601-1-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57Same
Eye safetyIEC 62471IEC 62471IEC 62471Same
Biocompatibi
lityISO 10993-5
ISO 10993-10ISO 10993-5
ISO 10993-10ISO 10993-5
ISO 10993-10Same

6

7

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

8

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 60601-1-11 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

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.