(59 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic sensor and light technology without mentioning any AI/ML components or functions.
No
The device is described as an over-the-counter hair removal device and its intended use is for the removal of unwanted body and/or facial hair, which is a cosmetic purpose rather than a therapeutic one for a medical condition.
No.
The device is intended for hair removal, which is a cosmetic procedure, not a diagnostic one used to identify a disease or condition. Its function is to reduce hair growth using Intense Pulsed Light (IPL) technology, and there is no mention of it being used to diagnose any medical condition.
No
The device description clearly states it is a physical device utilizing Intense Pulsed Light (IPL) technology with hardware components like a Xenon Lamp, skin sensor, and external power adapter. While software verification and validation were conducted, the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted body and/or facial hair." This is a cosmetic or aesthetic procedure performed directly on the body, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a light-based device that works below the skin's surface to reduce hair growth. This aligns with a physical treatment device, not a diagnostic one.
- Anatomical Site: The device is used on the skin (body and face) for hair removal. IVDs typically interact with biological samples.
- Working Principle: The device uses Intense Pulsed Light (IPL) technology to affect hair follicles. This is a physical mechanism, not a chemical or biological assay used for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This IPL hair removal device does not fit that description.
N/A
Intended Use / Indications for Use
IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The IPL Hair Removal is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction 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 and its IPL emission activation is by finger switch. The device contains Xenon Lamp to emit light and skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse. The IPL Hair Removal includes two models, W-1095 and W-1098. The two models are the same in intended use, working principle, the main differences are appearance and output parameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Body and/or facial hair. Multiple hair removal areas, including small areas (e.g. armpit, bikini lines) and large areas (e.g. arms, legs).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testings have been conducted to verify that the IPL Hair Removal meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the subject device complies with the following standards:
- A IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A 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 1-11: 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
-
IEC 62471, Photobiological safety of lamps and lamp systems
The device has been tested for biocompatibility, it complies with the following standards. - A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted: - A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- A Usability evaluation according to the requirements of 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
September 14, 2023
Shenzhen Wochuan Electronic Co., Ltd % Tracy Che 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: K232124
Trade/Device Name: IPL Hair Removal, Model: W-1095, W-1098 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 12, 2023 Received: July 17, 2023
Dear Tracy Che:
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,
| Jianting | Digitally signed by
Jianting Wang -S |
|----------|-----------------------------------------|
| Wang -S | Date: 2023.09.14
16:11:07 -04'00' |
For 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) K232124
Device Name IPL Hair Removal, Model: W-1095, W-1098
Indications for Use (Describe)
IPL Hair Removal 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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3
510 (k) Summary K232124
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information:
| 510(k) owner's name: | Shenzhen Wochuan Electronic Co., Ltd |
|---|---|
| Address: | 6th Floor Building No.357 3rd Area A Huayuan Xingye 1 road, |
| Fenghuang Community, Fuyong Street, Baoan District, Shenzhen, | |
| Guangdong China | |
| Contact person: | Rebecca Jiang |
| Phone number: | +86 13823355685 |
| Fax number: | / |
| Email: | rebecca@szwoc.com |
| Date of summary prepared: | 2023-07-12 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name/model: | IPL Hair Removal, Model: W-1095, W-1098 |
|---|---|
| Common name: | Light Based Over-The-Counter Hair Removal |
| Regulation number: | 21 CFR 878.4810 |
| Product code: | OHT |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate and reference devices
Predicate devices A
| Primary predicate device | Predicate device | |
|---|---|---|
| Sponsor | Shenzhen | |
| Junbobeauty | ||
| Technology Co., Ltd. | Shenzhen Bosidin Technology | |
| Co.,Ltd. | ||
| Device Name and Model | IPL HAIR REMOVAL | |
| HANDSET | ||
| Model: IPL-666 | IPL Home Use Hair Removal | |
| Device | ||
| Model(s): D-1128, D-1103, | ||
| D-1119, D-1129, D-1130 | ||
| 510(k) Number | K220669 | K192432 |
| Product Code | OHT | OHT |
4
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
|---|---|---|
| Regulation Class | II | II |
> Reference device
| Sponsor | Glan Electronics Co., Ltd. |
|---|---|
| Device Name and Model | IPL Hair Removal, Model: OBT-02 |
| 510(k) Number | K213041 |
| Product Code | OHT |
| Regulation Number | 21 CFR 878.4810 |
| Regulation Class | II |
(5) Description/ Design of device:
The IPL Hair Removal is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction 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 and its IPL emission activation is by finger switch. The device contains Xenon Lamp to emit light and skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot trigger a pulse. The IPL Hair Removal includes two models, W-1095 and W-1098. The two models are the same in intended use, working principle, the main differences are appearance and output parameters.
(6) Indications for use:
IPL Hair Removal is an over-the-counter device intended for removal of unwanted body and/or facial hair.
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL Hair Removal | |||
| (Model: W-1095) | ABS+PS | Surface-contacting | |
| device: Intact skin | Less than 24 hours | ||
| IPL Hair Removal | |||
| (Model: W-1098) | ABS | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
(7) Materials
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".
(8) Technological characteristics and substantial equivalence:
5
| Item | Subject device | Primary predicate
device | Predicate device | Reference device | Remark |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Trade name | IPL Hair Removal,
Model W-1095,
W-1098 | IPL HAIR REMOVAL
HANDSET
Model: IPL-666 | IPL Home Use Hair
Removal Device
Model(s): D-1128,
D-1103, D-1119,
D-1129, D-1130 | IPL Hair Removal,
Model: OBT-02 | / |
| 510 (k)
number | Applying | K220669 | K192432 | K213041 | / |
| Manufacturer | Shenzhen Wochuan
Electronic Co., Ltd | Shenzhen Junbobeauty
Technology Co., Ltd. | Shenzhen Bosidin
Technology Co., Ltd. | Glan Electronics
Co., Ltd. | / |
| Regulation
number | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | OHT | Same |
| Class | II | II | II | II | Same |
| Indications
for
use/
Intended use | IPL Hair Removal is
an over-the-counter
device intended
for
removal of unwanted
body
and/or
facial
hair. | IPL HAIR REMOVAL
HANDSET is an over-
the-counter
device
intended for removal of
unwanted body and/or
facial hair. | IPL Home Use Hair
Removal Device is an
over-the-counter
device intended
for
removal of unwanted
body and/or facial hair. | 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
re-growing when
measured at 6, 9
and 12 months
after the
completion of a
treatment regime.
The device is used
for adults. | Same |
| Prescription
or OTC | OTC | OTC | OTC | OTC | Same |
| Applicable | Fitzpatrick
Skin | Fitzpatrick
Skin | Fitzpatrick
Skin | Unknown | Same |
| skin | Phototypes I-V | Phototypes I-V | Phototypes I-V | | Similar |
| Treatment
area | Multiple hair removal
areas, including small
areas (e.g. armpit,
bikini lines) and large
areas (e.g. arms, legs). | The device is designed
for use on the legs,
underarms,
bikini line, chest,
stomach, back, arms
and on the face below
the cheekbones. | Removal of unwanted
body hair such as but
not limited to small
areas such as underarm
and facial hair below
the chin line and large
areas such as legs. | Unknown | |
| Device design | | | | | |
| Power source | An external power
supply | An external power
supply | Supplied by external
power adapter | Supplied by
external adapter | Same |
| Power supply | 100240V AC Input240V AC Input
DC 12V 3A Output | 100
12V3A DC Output | Input:
100-240V
50/60Hz 1.0-0.5A
Output: DC12V 3A | 100-240 V AC | Same |
| Product
compositions | IPL Hair Removal
main device and
power adapter | IPL Hair Removal
Handset and power
adapter | IPL host, lamp
cartridge and power
adapter | IPL device and
power supply | Similar |
| Structure
design | Handheld | Handheld | Handheld | Handheld | Same |
| Dimension | W-1095:1636037mm
W-1098:170.568.543mm | 1248348.5mm | 218 x 144 x 60mm | 1507545mm
(HWD) | Different |
| Weight | W-1095:223.5g2.79J/cm² | 1.3-2.49J/cm² | 2.0
W-1098:256.92g | 186g | 355g | 220g | Different |
| Sterilization | Not required | Not required | Not required | Not required | Same |
| Output specification | | | | | |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed
Light | Same |
| Energy
medium | Xenon Arc flashlamp | Xenon Quartz Tube | Xenon lamp | Xenon Arc
Flashlamp | Same |
| Wavelength
range (nm) | 470nm 1100nm | 470nm 4.46J/cm²1100nm | Regular window: 5101100nm | Same |
~ 1100nm
Filter window: 600 ~
1100mm | 510nm
| Energy
density
(J/cm²) | W-1095:1.67
W-1098:1.164.0J/cm²4.5J/cm²
(applicable for
model D-1128,
D-1119, D-1129,
D-1130)
2.5
(Applicable for model
D-1103) | 1.5-4.0J/cm2 | Similar |
| Spot
size | W-1095: 2.69cm² | 3cm² | Regular window: | 3.0cm² | Similar |
| (Size of
treatment
window)
(cm²) | W-1098: 4.3cm² | | $4.5cm^2$ , $2.0cm^2$ ,
$3.0cm^2$
Filter window: 2.5cm² | | |
| Pulse
duration | 4-13ms | 11.5-15ms | 7.5-14ms | 3ms | 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 |
| Number of
output
channels | One channel | One channel | One channel | One channel | Same |
| Output
intensity
level | W-1095: 5 levels
W-1098: 3 levels | 5 levels | 5 levels | 5 levels | Similar |
| Skin sensor | Sensor fixed in device
and can be moved to
treatment part | Sensor fixed in handset
and can be moved to
treatment part | Sensor fixed in device
and can be moved to
treatment part | Sensor fixed in
device and can be
moved to treatment
part | Same |
| Software/
Firmware/
Microprocess
or
Control? | Yes | Yes | Yes | Yes | Same |
| Additional features | | | | | |
| Skin-
contacting
components | Enclosure and light
outlet | Plastic enclosure and
treatment window | Plastic enclosure and
treatment window | Enclosure and
treatment window | Same |
| Materials of
skin-
contacting
components | ABS, PS | Plastic, metal | ABS, PC, Aluminium
alloy | Unknown | Different |
| Biocompatibi
lity | All user directly
contacting materials
are compliance with
ISO10993-5 and
ISO10993-10
requirements. | All user directly
contacting materials
are compliance with
ISO10993-5 and
ISO10993-10
requirements. | All user directly
contacting materials
are compliance with
ISO10993-5 and
ISO10993-10
requirements. | All user directly
contacting
materials are
compliance with
ISO10993-5 and
ISO10993-10
requirements. | Same |
| Electrical
safety | IEC60601-1-2
IEC60601-1
IEC60601-1-11
IEC60601-2-83 | IEC60601-1-2
IEC60601-1
IEC60601-1-11
IEC60601-2-83 | IEC60601-1-2
IEC60601-1
IEC60601-1-11
IEC60601-2-57 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57 | Same |
| Photobiological safety | IEC62471 | IEC62471 | IEC62471 | Unknown | Same |
6
Shenzhen Wochuan Electronic Co., Ltd
510(k)s – Section 8. 510 (k) Summary
7
8
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the IPL Hair Removal meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the subject device complies with the following standards:
- A IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- A 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 1-11: 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
-
IEC 62471, Photobiological safety of lamps and lamp systems
The device has been tested for biocompatibility, it complies with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- A Usability evaluation according to the requirements of the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016"
(10) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Hair Removal is as safe, as effective, and performs as well as the legally marketed predicate devices and reference device.