(62 days)
No
The description focuses on the physical mechanism of IPL and does not mention any AI/ML components or functions.
No.
The device is intended for "removal of unwanted body and/or facial hair," which is a cosmetic purpose rather than a therapeutic one aimed at treating a disease or condition. While it causes "thermal damage to target chromophores," this is for hair reduction, not for healing or alleviating a medical condition.
No
The device is intended for hair removal, which is a therapeutic or cosmetic purpose, not for diagnosing a condition or disease.
No
The device description explicitly states it is an "Intense Pulsed Light (IPL)" device and describes physical components like an external power adapter and a finger switch for IPL emission. It also mentions performance studies related to electrical safety, eye safety, and bench testing of physical parameters like output energy density and pulse duration, all indicative of a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The IPL Hair Removal Device works by applying light energy directly to the skin to target hair follicles. It does not involve the collection or analysis of any biological specimens.
- Intended Use: The intended use is for the removal of unwanted body and/or facial hair, which is a cosmetic or aesthetic purpose, not a diagnostic one.
The description clearly indicates that the device is a light-based system used for a physical process on the body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device 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
IPL 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 3 models with the same IPL technology for hair removal, which is model JM-843, M-865, JM-638. 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 is by finger switch.
IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 530-1200m and 500-1200m. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores thermal relaxation time but sparing normal skin by limiting the thermal relaxation time for skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing:
The biocompatibility evaluation for the body-contacting components of the subject 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", 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 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
- ISO 10993-23:2021. Biological evaluation of medical devices -Part 23: Tests for skin irritation
- Electrical Safety and EMC:
Electrical safety and EMC testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic 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
- Eye Safety:
- IEC 62471 Photobiological safety of lamps and lamp systems
-
Software Verification and Validation:
Software documentation consistent with basic documentation level was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and have been mitigated to acceptable risk levels. -
Performance (bench) testing:
Verification Report of Times of Flash: The valid IPL emission number (IPL shot counts) of the lamp tube is used to as the service life of the IPL Hair Removal Device. The service life as 300,000 times.
In order to verify and assure the performance, function and quality of the IPL Hair Removal Device, we have conducted the verification of output energy density, pulse duration time, valid times of flashes and Cold Compress Temperature.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2024
Shenzhen Junmei Technology Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K241881
Trade/Device Name: IPL Hair Removal Device (JM-843, JM-865, JM-638) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: June 21, 2024 Received: June 28, 2024
Dear Youshan Gong:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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 Digitally signed by TANISHA L. L. HITHE - HITHE -S Date: 2024.08.29 STE 14:10:22 -04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241881
Device Name
IPL Hair Removal Device (JM-843, JM-865, JM-638)
Indications for Use (Describe)
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K241881 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2024-8-28
. Submitter
SHENZHEN JUNMEI TECHNOLOGY CO., LTD. Plant 4301, Yili Science Park, No.596-4, Dahe Village, Guancheng Community, Guanhu Street, Longhua District, Shenzhen, Guangdong, China Post code: 518100 Tel.: 0755-29015600
Guo Zenghui Management representative Tel: +86-13510281409 E-mail: 810452380@qq.com
ll. Device
Name of Device: IPL Hair Removal Device Model(s): JM-843,JM-865,JM-638 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
5
| Manufacturer | Predicate Device | 510(k)
Number |
|--------------------------------------------------------------------|-------------------------------------|------------------|
| Shenzhen Beauty
EveryMoment
intelligent electric
Co.,Ltd. | IPL Home Use Hair
Removal Device | K221001 |
➤ Reference Device 1
| Manufacturer | Reference Device | 510(k)
Number |
|-------------------------------------------------------------|---------------------|------------------|
| Shenzhen Jianchao
Intelligent
Technology Co.,
Ltd. | Hair Removal Device | K232575 |
Reference Device 2 A
| Manufacturer | Reference Device | 510(k)
Number |
|-----------------------------------------------------|-------------------------|------------------|
| Shenzhen BSX
Technology
Electronics Co., Ltd. | IPL Hair Removal Device | K230097 |
IV. Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (PL), and it has been designed 3 models with the same IPL technology for hair removal, which is model JM-843, M-865, JM-638. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth
6
with minimal pain.
The device is only powered by the external power adapter and its IPL emission is by finger switch.
IPL Hair Removal Device is a Pulsed Light system which emits intense pulsed light (IPL) at a wavelength ranging from 530-1200m and 500-1200m. The device works on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores thermal relaxation time but sparing normal skin by limiting the thermal relaxation time for skin.
V. Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
VI. Materials
| Model | Contacted Component Name | Materials |
|---|---|---|
| JM-843,JM-865,JM- | ||
| 638 | Host of machine (including air outlet, | |
| treatment window, air inlet, buttons) | ABS, PC |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section Biocompatibility evaluation report.
VII. Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device has the same intended use as the predicate. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate device and reference devices. Any minor differences between the subject device and the listed predicate device and reference devices 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 devices for its intended use.
7
IPL Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, material, specifications and performance:
| Comparison Elements | Subject Device | | Predicate Device | Reference
Device 1 | Reference
Device 2 | Remark |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Model | JM-843, JM-865 | JM-638 | D-1189 | R2815-G Pro,
R2815-G | BSXT101 | |
| 510(k) Number | Pending | | K221001 | K232575 | K230097 | / |
| Trade name | IPL Hair Removal Device | | IPL Home Use
Hair Removal
Device | IPL Hair
Removal
Device | IPL Hair
Removal
Device | / |
| Manufacturer | SHENZHEN JUNMEI TECHNOLOGY CO.,
LTD. | | Shenzhen Beauty
EveryMoment
intelligent
electric Co.,Ltd. | Shenzhen
Jianchao
Intelligent
Technology
Co., Ltd. | Shenzhen
BSX
Technology
Electronics
Co., Ltd. | / |
| Regulation number | 21 CFR 878.4810 | | 21 CFR 878.4810 | 21 CFR
878.4810 | 21 CFR
878.4810 | Same |
| Product code | OHT | | OHT | OHT | OHT | Same |
| Device classification | Class II | | Class II | Class II | Class II | Same |
| Indication for use/
Intended use | The IPL Hair Removal Device 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. | Hair Removal
Device is an
over-the-
counter device
intended for
removal of
unwanted
body hair
and/or facial
hair. | The IPL Hair
Removal
Device is an
over-the-
counter
device
intended for
removal of
unwanted
body and/ or
facial hair. | Same |
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference
Device 2 | Remark | |
| Prescription or OTC | OTC | OTC | OTC | OTC | Same | |
| Applicable skin | Fitzpatrick skin types I-V | Fitzpatrick skin types I-V | Fitzpatrick Skin Types I-V | Fitzpatrick
Skin Types I-V | Same | |
| Power supply | 100-240V, 50/60Hz | 100-240V, 50/60Hz | 100-240V, 50/60Hz | 100-240V, 50/60Hz | Same | |
| Dimension | 1949155 mm | 1328052 mm | 1976038 mm | 19411745mm | 190 x 70 x 45 mm | Different
Note 1 |
| Sterilization | Not required | Not required | Not required | Not required | Same | |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same | |
| Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc lamp | Same | |
| Wavelength range | 530nm1200nm | 500nm1200nm | 5501100nm | 5301200nm | 4701200nm | Same |4.3J/cm²
| Energy density | 1.94 ~ 5.45 J/cm² | 1.20 ~ 4.00 J/cm² | 2.0
(±20%) | Max 5.2 J/cm² | Max 5.0 J/cm² | Similar
Note 2 |
| Output energy | 8J ~ 15J, ±20%
BODY: 8/10/11.5/13/15 J
FACE:
8.5/9.5/10.5/11.5/12.5 J
PRIVATE PARTS:
8.5/10/11/12.5/13.5 J
ALL: 8.5 J | 4.5J ~ 10J, ±20%
Mode 1:
4.5/6/7.5/8.5/10 J | Body:
6/7.5/9/10.5/12
Face:
6/7.5/9/10.5/12
Bikini:
6/7.5/9/10.5/12
Underarm:
7.5/8.6/9.7/10.8/12
(±20%) | 5-14.5J | Pure mode:
510J10J
(±20%)
Armpit mode: 6
(±20%)
Body mode:
6.511J12.5J | Similar
(±20%)
Bikini mode:
8
Note 2 |
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference
Device 2 | Remark | |
| | | | | (±20%) | | |
| Spot size | $3.3cm^2 \pm 0.25cm^2$ | $3.0cm^2 \pm 0.25cm^2$ | $3.0cm^2$ | $3.4cm^2 \pm 0.5cm^2$ | $3.0cm^2 \pm 0.5cm^2$ | Similar
Note 3 |
| Pulse duration | 10.2±1ms | 9.0±1 ms | 512ms+/-20% | 8.5±2.5ms | 4-10ms | Same |5 levels | 1
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same | |
| Output intensity level | 15 levels | 15 levels | 19 levels | 15 levels | Same |
| Software/
Firmware/
Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | 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
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | ANSI AAMI
ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | Same |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | Same |
8
9
Note 1:
10
Though the dimension is different from the predicate device, this difference is insignificant and do not raise any safety or effectiveness problems.
Note 2:
Though the energy density and the output energy of subject device is a little different from the predicate device and reference device, consider the error ±20%, the energy density and the output energy of subject device is similar to the predicate device and reference device, and they all comply with IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
Note 3:
There is minor difference in spot size between the subject device. The spot size is related to energy density while the energy density of subject device is the same as explained in Note 2, so this difference is not significant and 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 subject 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", 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 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
-
ISO 10993-23:2021. Biological evaluation of medical devices -Part 23: Tests for skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance A
11
- 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
- A IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with basic documentation level was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and have been mitigated to acceptable risk levels.
5) Performance (bench) testing
Verification Report of Times of Flash: The valid IPL emission number (IPL shot counts) of the lamp tube is used to as the service life of the IPL Hair Removal Device. The service life as 300,000 times.
In order to verify and assure the performance, function and quality of the IPL Hair Removal Device, we have conducted the verification of output energy density, pulse duration time, valid times of flashes and Cold Compress Temperature.
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.