(59 days)
No
The description focuses on standard IPL technology, a skin tone sensor for safety, and basic usability testing. There is no mention of AI, ML, or any related concepts in the device description, performance studies, or key metrics.
No.
The primary purpose of the device is the removal of unwanted hair, which is a cosmetic application rather than treating a disease or condition. While it provides "reduction of hair growth," this is not presented as a therapeutic benefit for a medical condition.
No
The device is intended for hair removal, which is a cosmetic procedure, not for diagnosing any medical condition.
No
The device description explicitly states it is an "IPL hair removal device" that uses Intense Pulsed Light (IPL) technology, contains a Xenon lamp, a skin tone sensor, and is powered by an external adapter. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "removal of unwanted body and facial hair." This is a cosmetic or aesthetic purpose, not a diagnostic one.
- Device Description: The description focuses on the mechanism of hair reduction using IPL technology and safety features like the skin tone sensor and contact sensor. There is no mention of analyzing biological samples (like blood, urine, or tissue) or providing information about a person's health status or condition.
- Lack of Diagnostic Elements: The document does not mention any features related to diagnosing, monitoring, or treating a disease or condition based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This IPL hair removal device does not fit that definition.
N/A
Intended Use / Indications for Use
The product is an over-the-counter device intended for removal of unwanted body and facial hair.
Product codes
OHT
Device Description
IPL hair removal device is a personal, light-based, hair reduction device intended to be sold over-thecounter 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 a Xenon lamp and a skin tone 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 be triggered a pulse emitting.
The IPL hair removal device includes LS101 and LS102 two models. Their intended use, performance, structure design and operation are identical, with the different color of grip part. The difference does not affect or change the intended use of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-counter / Home Healthcare Environment
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)
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, including:
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity
- A ISO 10993-10:2010 Biological evaluation of medical devices-Part 10:Tests for irritation and skin sensitization
- A ISO 10993-10:2021 Biological evaluation of medical devices-Part 10:Tests for skin sensitization
2) Electrical Safety and Eye Safety
- A 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 A essential performance –Collateral standard: electromagnetic compatibility
- A 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
- A IEC 60601-2-57 Medical electrical equipment –Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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) OTC Usability Study
An OTC Usability Study was enrolled a total of 20 participant and was conducted to provide a basis for the Company to gather data from the layperson relative to level of labeling understanding of what the device is, what the device does and how to operate the device. This Study was completed successfully and the results were no issues or negative comments.
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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 28, 2023
Lumenessa Corp % Xuexia Ren Director Chengdu Office Delta Technology Service (Shenzhen) Co., Ltd. 1-01, Building 1&1-01 A-01, Building3, No.15 Jinhui Rd. Kengzi Subdistrict, Pingshan District Shenzhen, 518118 China
Re: K232274
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 28, 2023 Received: July 31, 2023
Dear Xuexia Ren:
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/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 (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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tanisha L. Tanisha L. Hithe -S 2023.09.28 Hithe -S 10:57:51 -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
510(k) Number (if known) K232274
Device Name IPL hair removal device
Indications for Use (Describe)
The product is an over-the-counter device intended for removal of unwanted body and 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
Chapter 6, 510(k) Summary
510(k) Summary K232274
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
- 510(k) Owner's Name: Lumenessa Corp �
- Establishment Registration Number: Applying �
- Address: 10606 Shoemaker Ave #A, Santa Fe Springs, CA 90670 �
- Tel: 1-408-5623072121 �
- � Fax: /
- � Contact Person: Peter Kim (Vice President)
- Email: peter@lumenessa.com �
- � Date Prepared: September 26, 2023
Application Correspondent:
- Contact Person: Ms. Ren Xuexia �
- � Delta Technology Service(Shenzhen) Co., Ltd.
- Address: 1-01, Building 1&1-01 A-01, Building3, No.15 Jinhui Rd., Kengzi Subdistrict, Pingshan � District, Shenzhen, 518118, China
- � Tel: +86-18030755441
- � Email: renxuexia@deltates.com
2. Subject Device Information
- � Common Name: Light Based Over-The-Counter Hair Removal
- Trade Name: IPL hair removal device (Model: LS101, LS102) �
- � Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
- � Review Panel: General & Plastic Surgery
- Product Code: OHT �
- � Regulation Number: 878.4810
- � Requlation Class: II
3. Predicate Device Information Predicate Device 1 Information
- � Common Name: Light based over the counter hair removal system
- 510(k) Number: K160968 �
- � Sponsor: CyDen Limited.
- Trade Name: iPulse SmoothSkin Gold Hair Removal Device �
- Classification Name: Laser surgical instrument for use in general and plastic surgery and in � dermatology
5
- � Review Panel: General & Plastic Surgery
- � Product Code: OHT, GEX
- Requlation Number: 878.4810 �
- � Regulation Class: II
Predicate Device 2 Information
- � Common Name: Light Based Over-The-Counter Hair Removal
- 510(k) Number: K161428 �
- � Sponsor: Shen Zhen CosBeauty Co., Ltd
- � Trade Name: PerfectSmooth
- Classification Name: Laser surgical instrument for use in general and plastic surgery and in � dermatology
- � Review Panel: General & Plastic Surgery
- � Product Code: OHT
- � Regulation Number: 878.4810
- � Regulation Class: II
4. Device Description
IPL hair removal device is a personal, light-based, hair reduction device intended to be sold over-thecounter 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 a Xenon lamp and a skin tone 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 be triggered a pulse emitting.
The IPL hair removal device includes LS101 and LS102 two models. Their intended use, performance, structure design and operation are identical, with the different color of grip part. The difference does not affect or change the intended use of the device.
5. Intended Use / Indications for Use
The product is an over-the-counter device intended for removal of unwanted body and facial hair.
6. Test Summary
IPL hair removal device, Model: LS101, LS102 has been evaluated for the safety and performance by lab bench testing as following:
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, including:
-
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for In Vitro Cytotoxicity
- A ISO 10993-10:2010 Biological evaluation of medical devices-Part 10:Tests for irritation and skin sensitization
- A ISO 10993-10:2021 Biological evaluation of medical devices-Part 10:Tests for skin sensitization
6
| Sponsor: | Lumenessa Corp |
|---|---|
| Subject Device: | IPL hair removal device, Model: LS101, LS102 |
| Document Name: | FDA 510(k) Submission Report |
2) Electrical Safety and Eye Safety
- A 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 A essential performance –Collateral standard: electromagnetic compatibility
- A 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
- A IEC 60601-2-57 Medical electrical equipment –Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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) OTC Usability Study
An OTC Usability Study was enrolled a total of 20 participant and was conducted to provide a basis for the Company to gather data from the layperson relative to level of labeling understanding of what the device is, what the device does and how to operate the device. This Study was completed successfully and the results were no issues or negative comments.
7. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of IPL hair removal device (Model: LS101, LS102) is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new question of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Device Name | IPL hair removal device | |||
| Model: LS101, LS102 | iPulse SmoothSkin Gold | |||
| Hair Removal Device | PerfectSmooth | -- | ||
| 510(k) Number | K232274 | K160968 | K161428 | -- |
| Indications for Use | The product is an over- | |||
| the-counter device | ||||
| intended for removal of | ||||
| unwanted body and | ||||
| facial hair. | The iPulse SmoothSkin | |||
| Gold Hair Removal System | ||||
| is an over the counter | ||||
| device intended for the | ||||
| removal of unwanted hair. | The PerfectSmooth is an | |||
| over-the-counter device | ||||
| intended for removal of | ||||
| unwanted 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. | SE | |||
| Note 1 |
7
| Sponsor: | Lumenessa Corp |
|---|---|
| Subject Device: | IPL hair removal device, Model: LS101, LS102 |
| Document Name: | FDA 510(k) Submission Report |
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Wavelength range | 523nm ~ 1100nm | 510-1100nm | ≥510nm | SE |
| Note 2 | ||||
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | SE |
| Energy density | 3.2-6.5J/cm² | 3-6J/cm² | 4.7 J/cm² | SE |
| Note 3 | ||||
| Spot size | Standard care head: | |||
| 3cm²(30mm*10mm) | ||||
| Precision care head: | ||||
| 1.2cm²(12mm*10mm) | 3cm² (3cm by 1cm) | 4.5 cm² | SE | |
| Note 2 | ||||
| Pulse duration |