(62 days)
No
The description focuses on standard IPL technology, safety features like skin contact sensors, and electrical/biocompatibility testing. There is no mention of AI, ML, or any features that would suggest adaptive learning or complex data processing beyond basic sensor input.
No.
The device is intended for the removal of unwanted hair, which is a cosmetic purpose rather than a therapeutic one (treating or alleviating a disease or injury).
No
The device is an intense pulsed light therapy apparatus intended for the removal of unwanted hair, which is a treatment/therapy function, not a diagnostic one.
No
The device description explicitly details hardware components such as an external power adapter, switch, auto light emission, and a skin sensor, and the performance studies include electrical safety and biocompatibility testing, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "removal of unwanted body and/or facial hair." This is a cosmetic or therapeutic purpose, not for diagnosing a disease or condition based on in vitro examination of specimens.
- Device Description: The description focuses on the mechanism of action (IPL technology for hair reduction) and safety features (skin sensor, power source). It does not mention any interaction with biological samples or the analysis of such samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, this device falls under the category of a light-based device for hair removal, which is not considered an IVD.
N/A
Intended Use / Indications for Use
Intense pulsed light therapy apparatus 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
Intense pulsed light therapy apparatus is an over-the-counter, home-use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device includes 12 model: FDA01, FDA02, FDA03, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), the model name with an "S" indicates that the model has a cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and the device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home 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)
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 Intense Pulsed Light Therapy Apparatus 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 specified testing was performed and passed.
-
Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the specified standards.
-
Eye Safety: IEC 62471 Photobiological safety of lamps and lamp systems.
-
Software Verification and Validation: Software documentation consistent with moderate level of concern was submitted. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
-
Usability: The product usability has been evaluated according to 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 logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2024
Qiaocheng Li (Dongguan) Medical Instruments Co., LTD % Riley Chen RA Engineer Feiving Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K241120
Trade/Device Name: Intense pulsed light therapy apparatus (FDA01. FDA02. FDA04S. FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) 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: April 22, 2024 Received: April 23, 2024
Dear Riley Chen:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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/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.
1
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.
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 OS 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 (OS) 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-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,
Digitally signed
Tanisha L. by Tanisha L.
Hithe -S
Hithe -S
Date: 2024.06.24
15:29:23 -04'00'
Tanisha Hithe 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
Indications for Use (Describe)
Intense pulsed light therapy apparatus 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)
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."
4
510(k) Summary
K241120
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Qiaocheng Li (Dongguan) Medical Instruments Co., LTD Room 302, Building 5, No.6, Lianhu Baoyuan Road, Tangxia Town, Dongguan City, Guangdong Province, China Post code: 523712
Huang Quanhua Title: Quality supervisor Tel.: +86-18681107912 Email: 1s4 5ogp59ash7@dingtalk.com Date: 2024.05.27
II. Device
Name of Device: Intense pulsed light therapy apparatus Model(s): FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S 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 & Reference Device
Predicate devices:
| Manufacturer | Predicate Device | 510(k) Number | Cleared Date |
|---|---|---|---|
| Zhuzhou Goldenhot | |||
| Medical Technology | |||
| Co., Ltd. | Intense pulsed light device, | ||
| Model(s): DE01A-B, DE01A-G, | |||
| DE01B-B, DE01BG, DE01C-B, | |||
| DE01C-G, DE02A-B, DE02A-G, | |||
| DE02B-B, DE02B-G, DE02C-B, | |||
| DE02C-G. | K231613 | Jul. 31, 2023 | |
| Shenzhen Fansizhe | |||
| Science And | |||
| Technology Co., Ltd | Intense Pulsed Light (IPL) System, | ||
| model T013C, T015C, T015K | K221569 | Jun. 30, 2022 |
Reference device:
5
| Manufacturer | Reference Device | 510(k) Number | Cleared Date |
|---|---|---|---|
| Glan Electronics Co., Ltd. | IPL Hair Removal Device, model | ||
| OBT-02 | K213041 | Nov. 18, 2021 |
IV. Device Description
Intense pulsed light therapy apparatus is an over-the-counter, home-use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device includes 12 model: FDA01, FDA02, FDA03, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), the model name with an "S" indicates that the model has a cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and the device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses.
V. Indications for Use
Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.
VI. Materials
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Intense | |||
| pulsed | |||
| light | |||
| therapy | |||
| apparatus | |||
| (light | |||
| outlet, enclosure) | ABS+PC+POM | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
VII.Comparison of Technological Characteristics With the Predicate Device
Intense pulsed light therapy apparatus has the same intended use as the predicate devices. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate devices and reference device. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices and reference device for its intended use.
Intense pulsed light therapy apparatus is compared with the following Predicate Devices in terms of intended use, design, specifications and performance:
6
| Comparison
Elements | Subject Device | Primary Predicate
Device | Secondary predicate
device | Reference device | Remark | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------|
| 510(k) Number | K241120 | K231613 | K221569 | K213041 | / | |
| Trade name | Intense pulsed light therapy
apparatus | Intense pulsed light device | Intense Pulsed Light (IPL)
System | IPL Hair Removal
Device | / | |
| Model | FDA01, FDA02, FDA03,
FDA06, FDA07, FDA08
FDA04S, FDA05S, FDA06S,
FDA07S, FDA09S, FDA10S | DE01A-B, DE01A-G,
DE01B-B, DE01BG,
DE01C-B, DE01C-G,
DE02A-B, DE02A-G,
DE02B-B, DE02B-G,
DE02C-B, DE02C-G. | T013C, T015C, T015K | OBT-02 | / | |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same | |
| Product code | OHT | OHT | OHT, ONF | OHT | Same | |
| Device
classification | Class II | Class II | Class II | Class II | Same | |
| Indication for use/
Intended use | Intense pulsed light therapy
apparatus is an over-the-
counter device intended for
removal of unwanted body
and/or facial hair. | The Intense pulsed light
device is an over-the-
counter device, intended
for removal of unwanted
body and/or facial hair. | The Intense Pulsed Light
(IPL) System is an over-the-
counter device intended for
the removal of unwanted
body 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 | Same | |
| Comparison
Elements | Subject Device | Primary Predicate
Device | Secondary predicate
device | Reference device | Remark | |
| | | | | treatment regime.
The
device is used for adults. | | |
| Prescription
or
OTC | OTC | OTC | OTC | OTC | Same | |
| Environment
of
Use | Home use | Home use | Home use | Home use | Same | |
| Design | Hand-hold | Hand-hold | Hand-hold | Unknown | Same | |
| Power source | An external power supply | An external power adapter | An external power adapter | Supplied by external
adapter | Same | |
| Power supply | Input: 100-240V~, 50/60Hz | Input: AC 100 ~ 240V,
50/60 Hz, 1.0A | Input:
100-240V
50/60Hz, 1.5A Max. | 100-240 V AC | Similar | |
| Sterilization | Not required | Not required | Unknown | Not required | Same | |
| Light source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same | |
| Energy medium | Xenon lamp | Xenon Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same | |
| Wavelength range | 510-1200nm (±15nm) | 510nm1200nm | 510nm1200nm | 510-1100nm | Same | |
| Energy density | FDA01, FDA02, FDA03,
FDA04S, FDA06, FDA06S,
FDA07, FDA07S, FDA08,
FDA10S: 1.22.64J/cm²3.5J/cm² | 1.2
FDA05S, FDA09S:
1.34.1 J/cm² | 1.174.69J/cm² for T015C | 1.5-4.0J/cm² | Similar | |
| Spot size | 3.0cm² | 3.9 cm² | 3.5cm² for T015C | 3.0cm² | Similar | |
| Pulse duration | 3.54.5ms (±0.9ms) | Body mode: 7.09.0 (±2.0)ms
Face mode: 8.010.0 (±2.0)ms11.0 | 4~12ms for T015C | 3ms | Similar | |
Bikini mode: 9.0
| Comparison
Elements | Subject Device | Primary Predicate
Device | Secondary predicate
device | Reference device | Remark | |
| Pulsing control | Finger switch | $(±2.0)ms$
Finger switch | Finger switch | Finger switch | Same | |
| Output
intensity
level | 5 levels | 5 levels | Unknown | 5 Levels | Same | |
| Delivery device | Direct illumination to tissue | Direct Illumination to
Tissue | Direct Illumination to
Tissue | Direct illumination
to tissue | Same | |
| Software/
Firmware/
Microprocessor
Control? | 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 | ANSI AAMI ES60601-1
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 | Same | |
| | Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Unknown | 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 | Same |
7
8
9
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 Intense Pulsed Light Therapy Apparatus 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: 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 irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per 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 1-11: 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
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 according to the following FDA guidance: > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
10
Summary
Based on the above performance as documented in this application, the Intense Pulsed Light Therapy Apparatus was found to have a safety and effectiveness profile that is similar to the predicate devices.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.