(90 days)
Not Found
No
The description focuses on the hardware (IPL technology, Xenon lamp, skin sensor) and basic operational modes (automatic/manual, energy levels). There is no mention of AI/ML terms, data processing for learning, or performance metrics typically associated with AI/ML algorithms. The skin sensor is a simple contact detection mechanism, not indicative of AI/ML.
No.
A therapeutic device is one that treats a disease or condition. This device is intended for removal of unwanted hair, which is a cosmetic purpose, not a medical treatment.
No
The device is intended for hair removal, a therapeutic or cosmetic purpose, not for diagnosing a disease or condition.
No
The device description explicitly states it is a "light-based device" utilizing "Intense Pulsed Light (IPL) technology" and contains a "Xenon lamp" and a "skin sensor," indicating it is a hardware device with physical components that emit light and interact with the user's skin.
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 therapeutic purpose, not a diagnostic one.
- Device Description: The device uses Intense Pulsed Light (IPL) to heat hair roots and reduce hair growth. This is a physical treatment applied to the body, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are defined as medical devices and accessories used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such tests.
The device is clearly described as an over-the-counter device for hair removal, which falls under the category of medical devices used for cosmetic or therapeutic purposes, not diagnostics.
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
OHT
Device Description
The IPL Hair Removal Device is a light-based device and an over-the-counter device which is expected to be sold directly to end users. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. 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 has two working modes, an automatic mode and a manual mode. Each mode has 5 levels of output energy. The device contains a Xenon lamp that emits pulses of light (a total of 350000 pulses over the device's lifetime) and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), it will 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
Over-the-counter device, sold directly to end users.
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 Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
7.2. Biocompatibility Test
7.3. Software Verification and Validation
No new clinical performance data is reported in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 21, 2021
Zhongshan Bisen Plastic Electronic Products Co., Ltd. % Mark Leung Consultant Shenzhen Joyantech Consulting Co.,Ltd. 1713A, Block A, Zhongguan Times Square Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China
Re: K212314
Trade/Device Name: IPL Hair Removal Device 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 16, 2021 Received: July 23, 2021
Dear Mark Leung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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 and Part 809; 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,
Purva Pandya 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) K212314
Device Name IPL Hair Removal Device
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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
VOL_005_510(k) Summary 001_510(k) Summary
Product: IPL Hair Removal Device
Version: A/2
510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
| 1. | Administrative Information |
|---|---|
| ---- | ---------------------------- |
| Submission Date | July 16, 2021 |
|---|---|
| Manufacturer | |
| information | Zhongshan Bisen Plastic Electronic Products Co., Ltd. |
| Address: | |
| Second Floor, A Building, No.32 JianYe Road, Torch | |
| Development Zone | |
| Zhongshan City Guangdong, CN 528437. | |
| Contact person: Rao Guanhua | |
| TEL: +86(760)88297142 | |
| E-Mail: 376299441@qq.com | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China. | |
| Contact person: Mr. Mark Leung; Mr. Field Fu | |
| E-Mail: mark_leung@cefda.com; field@cefda.com | |
| Image: logo | |
| Establishment | |
| registration number | 3010564031 |
2. Device Information
| Type of 510(k) | Traditional |
|---|---|
| Submission: | |
| Device Name: | IPL Hair Removal Device |
| Model: | BZ-0721 |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery |
| and in dermatology | |
| Review Panel: | General & Plastic Surgery |
| Device Class: | 2 |
| Regulation Number: | 878.4810 |
| Product Code: | OHT |
-
- Predicate Device
4
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
VOL 005 510(k) Summary 001_510(k) Summary Version: A/2
Product: IPL Hair Removal Device
| Manufacturer: | Shenzhen Bosidin Technology Co.,Ltd. |
|---|---|
| Device Name: | IPL Home Use Hair Removal Device |
| Model: | D-1128 |
| 510(K) Number: | K192432 |
| Product Code: | OHT |
Device Description 4.
The IPL Hair Removal Device is a light-based device and an over-the-counter device which is expected to be sold directly to end users. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. 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 has two working modes, an automatic mode and a manual mode. Each mode has 5 levels of output energy. The device contains a Xenon lamp that emits pulses of light (a total of 350000 pulses over the device's lifetime) and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), it will cannot emit the treatment light pulses.
5. 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.
5
| Zhongshan Bisen Plastic Electronic Products Co., Ltd. | VOL_005_510(k) Summary
001_510(k) Summary |
| ------------------------------------------------------- | ---------------------------------------------- |
|---|
Product: IPL Hair Removal Device
Version: A/2
6. Comparison with predicate device
| ID | Comparison
Items | Subject Device | Predicate Device (K192432) | Comparison |
|----|-------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 1 | Device name | IPL Hair Removal Device | IPL Home Use Hair Removal Device | / |
| 2 | Model | BZ-0721 | D-1128 | / |
| 3 | Classification
Name | Laser surgical instrument for use in general and plastic
surgery and dermatology | Laser surgical instrument for use in general and plastic
surgery and dermatology | Same |
| 4 | Product Code | OHT | OHT | Same |
| 5 | Regulation
Number | 878.4810 | 878.4810 | Same |
| 6 | Class | II | II | Same |
| 7 | Prescription or
OTC | OTC | OTC | Same |
| 8 | Indications for
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. | Same |
| 9 | Source Energy | Supplied by external adapter | Supplied by external adapter | Same |
| 10 | Technology | Intense Pulsed Light (IPL) | Intense Pulsed Light (IPL) | Same |
| 11 | Energy medium | Xenon lamp | Xenon lamp | Same |
| 12 | Pulsing Control | Finger switch | Finger switch | Same |
| 13 | Delivery device | Direct illumination
to tissue | Direct illumination
to tissue | Same |
| ID | Comparison Items | Subject Device | Predicate Device (K192432) | Comparison |
| 14 | Wavelength | 510nm1100nm | Regular window: 510-1100nm4.0J/cm² | Comparable
Filter window: 600-1100nm | Comparable
(1) See below |
| 15 | Energy density | 1.5-3.0 J/cm² | 2.0
(2) See below |
| 16 | Spot Size | 4cm² | Regular window: 4.5cm², 2.0cm², 3.0cm²
Filter window:2.5cm² | Comparable
(3) See below |
| 17 | Output energy | 6.0J ~ 11.8J | 4.0J ~ 18.0J | Comparable
(4) See below |
| 18 | Pulse duration | 10.4ms | 7.5~14ms | Comparable
(5) See below |
| 19 | Weight | 333g | Unknown | Comparable
(6) See below |
| 20 | Dimension | 169.0x81.0x197.0mm (H x W x D) | Unknown | Comparable
(6) See below |
| 21 | Applicable
standards | ANSI AAMI 60601-1
IEC 60601-1-11
IEC 60601-1-2
IEC 60601-2-57
ISO 10993-5
ISO 10993-10 | IEC 60601-1
IEC 60601-1-11
IEC 60601-1-2
IEC 60601-2-57
ISO 10993-5
ISO 10993-10 | Same |
| ID | Comparison
Items | Subject Device | Predicate Device (K192432) | Comparison |
| | | IEC 62471 | IEC 62471 | |
6
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
VOL_005_510(k) Summary 001_510(k) Summary
Product: IPL Hair Removal Device
Version: A/2
7
Zhongshan Bisen Plastic Electronic Products Co., Ltd.
VOL_005_510(k) Summary 001 510(k) Summary
Product: IPL Hair Removal Device
Version: A/2
Note:
(1) Wavelength:
The wavelength range differences between the subject and predicate device do not raise new concerns of safety and effectiveness for the power output levels.
(2) Energy density:
The energy density range differences between the subject and predicate device of safety and effectiveness. The energy density is the amount of light energy delivered per unit area. The energy density range is calculated according to the following formula:
Output energy (J) ---------Formula 1 Energy density(J/cm2) = Spot Size (cm2)
(3) Spot Size:
For the output spot size, there is a minor difference between the precicate device. The spot size differences between the subject and predicate devices do not raise new concerns of safety and effectiveness.
8
| Zhongshan Bisen Plastic Electronic Products Co., Ltd. | VOL_005_510(k) Summary
001_510(k) Summary |
|-------------------------------------------------------|----------------------------------------------|
| Product: IPL Hair Removal Device | Version: A/2 |
(4) Output energy:
The energy density is the amount of light energy delivered per unit area. According formula, the output energy can be calculated.
Output energy (J)= Energy density(J/cm2) × Spot Size (cm2) -------------Formula 2
The output energy range of predicate device is 4.0-18.0. The output energy of subject device. The output energy differences between the subject and predicate devices do not raise new concerns of safety and effectiveness.
(5) Pulse duration:
The pulse duration range of subject device is within the range of predicate device. The pulse the subject and predicate devices do not raise new concerns of safety and effectiveness.
(6) Weight and Dimension:
The weight and dimension differences between subject and predicate devices do not raise new concerns of safety and effectiveness.
9
Product: IPL Hair Removal Device
7. Non-Clinical Test Summary
7.1. Electromagnetic Compatibility and Electrical Safety Test
The subject device has passed safety and performance testing in according to following standards.
- ANSI AAMI ES60601-1:2005/(R)2012 and 1) A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for 2) basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
-
- IEC 60601-1-11:2015 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 60601-2-57:2011 Medical Electrical Equipment Part 2-57: Particular requirements for 4) the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
-
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
7.2. Biocompatibility Test
The subject device has passed biocompatibility tests in according to following standards.
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1) cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
7.3. 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.
8. Clinical Study
No new clinical performance data is reported in this submission.
9. Conclusion
The technological characteristics and indications for the subject device (IPL Hair Removal Device [Model: BZ-0721]) do not raise new types of questions regarding safety and effectiveness when compared to the predicate device (K192432). Based on its
10
| Zhongshan Bisen Plastic Electronic Products Co., Ltd. | VOL_005_510(k) Summary
001_510(k) Summary |
|-------------------------------------------------------|----------------------------------------------|
| Product: IPL Hair Removal Device | Version: A/2 |
technical characteristics, design, functional features, performance test data, and its indications for use as listed above, the subject device is considered to be substantially equivalent to the predicate device.