Beurer IPL 8500 device/ IPL VelvetSkin Pro

K181734 · Home Well Trading, Ltd. · OHT · Sep 19, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181734
• Device Name: Beurer IPL 8500 device/ IPL VelvetSkin Pro
• Applicant: Home Well Trading, Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Sep 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPL 8500 device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. IPL 8500 is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of treatment regimen.

Device Story

The Beurer IPL 8500 is a handheld, over-the-counter intense pulsed light (IPL) device for hair reduction. It utilizes selective photothermolysis, emitting light (475-1200nm) to disable hair regrowth. The device consists of a handheld applicator and an external power supply. It features integrated skin proximity and pigmentation sensors to ensure safe application; the device prevents pulse triggering if skin contact is incomplete or if the skin tone is too dark/tanned. Operated by the user at home, the device provides visual feedback via indicator LEDs regarding operational status. By disabling hair follicles, the device provides a long-term, stable reduction in hair regrowth, offering a cosmetic benefit to the user.

Clinical Evidence

No new clinical performance data was reported. Substantial equivalence is supported by bench testing, safety testing (IEC 60601 series, IEC 62471, FCC Part 15), and human factors validation studies. Human factors testing (n=25) demonstrated 100% success rate in label comprehension, self-selection, and usability tasks, confirming that OTC users can safely operate the device based on labeling alone.

Technological Characteristics

Handheld IPL device; 4.5 cm² or 2 cm² treatment windows. Emits 475-1200nm light; max fluence 5 J/cm². Features skin proximity and pigmentation sensors. Biocompatible materials per ISO 10993-1. Powered by external supply/charger. Software validated per IEC 62304. Safety standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-1-2, IEC 62471.

Indications for Use

Indicated for adults for the removal of unwanted body and/or facial hair and for permanent reduction in hair regrowth.

Regulatory Classification

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.

Predicate Devices

• sensiLight Mini device (K161089)
• Lumilisse hair remover (K172791)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 19, 2018

Home Well Trading LTD Martin Gurovich VP R&D Omar Hodge Building, Road Town Tortola, Vg

Re: K181734

Trade/Device Name: Beurer IPL 8500 device/ IPL VelvetSkin Pro 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, ONF Dated: June 26, 2018 Received: July 2, 2018

Dear Martin Gurovich:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Home Well Trading Ltd | Omar Hodge Building, Road Town,<br>Virging Island (British) VG 1110 |
|------------------------------------------|---------------------------------------------------------------------|
| Beurer IPL 8500 device – 510K submission | RD-18043 A0 |

# SECTION 04

## BEURER IPL 8500 DEVICE

## AN OVER-THE-COUNTER HOME USE DEVICE INTENDED FOR HAIR REDUCTION BASED ON INTENSE PULSED LIGHT (IPL)

## INDICATION FOR USE STATEMENT

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### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

### 510(k) Number (if known)

K181734

Device Name Beurer IPL 8500

### Indications for Use (Describe)

The IPL 8500 device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. IPL 8500 is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of treatment regimen.

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.

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| Home Well Trading Ltd | Omar Hodge Building, Road Town,<br>Virging Island (British) VG 1110 |
|------------------------------------------|---------------------------------------------------------------------|
| Beurer IPL 8500 device - 510K submission | RD-18043 A0 |

# SECTION 05

## BEURER IPL 8500 DEVICE

## AN OVER-THE-COUNTER HOME USE DEVICE INTENDED FOR HAIR REDUCTION BASED ON INTENSE PULSED LIGHT (IPL)

## 510(K) SUMMARY

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Omar Hodge Building, Road Town, Virging Island (British) VG 1110

Beurer IPL 8500 device – 510K submission

RD-18043 A0

## 510(K) SUMMARY FOR HOME WELL TRADING LTD.'S BEURER IPL 8500 DEVICE

DATE PREPARED: JUNE 26™, 2017

### 510(K) OWNER NAME 1.

Home Well Trading Ltd. Omar Hodge Building, Tortola, British Virgin Islands Phone: [phone].

Contact person name: Martin Gurovich, VP R&D

Phone: [phone], E mail: [e-mail]

### 2. DEVICE NAME

Common/Usual Name: Light based hair removal devices Proprietary/Trade name: Beurer IPL 8500 device or VelvetSkin Pro Classification: Beurer IPL 8500 device by Home Well Trading Ltd. has been classified as Class II device under the following classification names:

| Classification Name | Product<br>Code | Regulation<br>Number | Panel |
|----------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------|--------------------------------|
| Light Based Over-The-<br>Counter Hair Removal<br>and<br>Powered Light Based<br>Non-Laser Surgical<br>Instrument With Thermal<br>Effect | OHT<br>and<br>ONF | 878.4810 | General and Plastic<br>Surgery |

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### 3. PREDICATE DEVICES

Beurer IPL 8500 device by Home Well Trading Ltd. is substantially equivalent to the following Predicate Devices:

3.1 EL Global Trade Ltd.'s sensiLight Mini device,

cleared under 510(k) numbers: K161089 on July 8, 2016.

3.2 Conair Corporation's Lumilisse hair remover,

cleared under 510(k) number K172791 on January 18, 2018.

#### 4. DEVICE DESCRIPTION

The Beurer IPL 8500 device is an intense pulse light hair reduction device. Phototherapy (Light-based) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Beurer IPL 8500 device is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Beurer IPL 8500 device is 4.5 cm² or 2 cm2 (for large and precise treatment windows, respectively).

The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Beurer IPL 8500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.

Body contact materials were evaluated for biocompatibility with accordance to FDA's Memorandum – #G95 1, May 1, 1995 and ISO 10993-1:2009.

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| Home Well Trading Ltd | Omar Hodge Building, Road Town,<br>Virging Island (British) VG 1110 | |
|------------------------------------------|---------------------------------------------------------------------|-------------|
| Beurer IPL 8500 device – 510K submission | | RD-18043 A0 |

#### INTENDED USE 5.

The Beurer IPL 8500 device is an over the counter device intended for removal of unwanted body and/or facial hair in adults. The Beurer IPL 8500 device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Beurer IPL 8500 device relies on the same technology as both predicate devices: Intense Pulsed Light (IPL). The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:

- . Wavelength of the emitted light (spectrum): Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. The Beurer IPL 8500 device and the predicate devices utilize the same spectrum as the sensiLight mini predicate device (475-1200nm) and as the Lumilisse predicate device (550-1200nm).
- Fluence/flux defines the energy per area (e.g. joules per cm2) for the treatment. . The Beurer IPL 8500 device and the predicate devices deliver exactly the same maximum energy (5 joules/cm2).
- . Pulse duration – Provides for an efficient heating of the target molecule but not its surroundings. The Beurer IPL 8500 device and the predicate device sensiLight mini have exactly the same pulse duration.

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| Home Well Trading Ltd | Omar Hodge Building, Road Town,<br>Virgin Island (British) VG 1110 |
|------------------------------------------|--------------------------------------------------------------------|
| Beurer IPL 8500 device - 510K submission | RD-18043 A0 |

#### 7. PERFORMANCE DATA (BENCH)

Beurer IPL 8500 device by Home Well Trading Ltd. has been successfully tested through bench and safety tests to support the determination of substantial equivalence with predicate devices.

The Beurer IPL 8500 device has been tested and complies with the following voluntary recognized standards:

- 1. IEC 60601-1:2012/EN 60601-1:2013 (Ed. 3.1). Medical electric equipment-Part 1 General requirements for Basic safety and essential performance.
- 2. IEC 60601-1-11:2015 (Ed. 2). Medical electric equipment-Part 1: Collateral requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- 3. IEC 60601-2-57:2011 (Ed. 1). Medical electrical equipment-Part 2: Particular requirements for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetics/aesthetic use.
- 4. FCC part 15, Subpart B, Class B.
- 5. IEC 60601-1-2:2014 (Ed. 4) Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
- 6. IEC 62471:2006 (Ed. 1). Photo-biological safety of lamps and lamp systems.
- 7. Software Validation was conducted according to IEC 62304:2006 Medical device software - Software life cycle processes, and; FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices, dated May 11, 2005.
- 8. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process and with FDA's Memorandum - #G95 1, May 1, 1995, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (Blue Book Memo G95-1).

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Beurer IPL 8500 device – 510K submission

- 9. ISO/IEC 14971:2007 (BS EN ISO 14971:2012) Medical devices Application of risk management to medical devices.
- 10. CB IEC 62133:2012. Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
- 11. UN 38.3 Recommendations on the Transport of Dangerous Goods, Model Regulations: Lithium Battery Transporation

*For the complete list of tests and applicable standards see Beurer IPL 8500 device Traceability Analysis, RD-18203 (Appendix C- subsection 037).

Tests results are supporting all labeling claims in order to establish substantial equivalency.

### Human Factors Validation Testing

A human Factors Validation Testing was done to evaluate the HFE/ UE concerns, including label comprehension/self-selection and usability/user interface studies (one arm, simulated use and summative evaluation). In both studies, participants had received the labeling materials of the device, and given enough time to read it according to their own wish.

Labeling Comprehension/ Self Selection Study was aimed at demonstrating potential user comprehension of the device labeling (mainly the outer package) in order to decide if device use is appropriate for her. It had included three main questions regarding the intended use of the device, treatment areas and possibility to use the device according to the contraindication, with correct answers: "Yes" or "No", explenation and further validation by the moderator. A total of 25 participants, 4 men and 21 women, from age 23 to 75 years old (37 ± 14 years old) were enrolled to this study. Participants had different educational levels, as obtained by REALM testing with 28% below 9th grade level. All participants had met the

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| Home Well Trading Ltd | Omar Hodge Building, Road Town,<br>Virging Island (British) VG 1110 |
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| Beurer IPL 8500 device – 510K submission | RD-18043 A0 |

inclusion/ exclusion criteria and signed ICF. 100% of the participants had reported correct answers, as further validated by the moderator (k=1).

Usability/ User Interface Study was aimed at demonstrating the OTC user can correctly use the device, based on the labeling material for the intended aesthetic puspose. The study was focused on four use scenarios including 25 relevant tasks: "Getting to know the device and device set-up" (7 tasks), "self-preparation" (9 tasks), "device usage" (7 tasks) and "after usage" (2 tasks). None of the participants had required assistance from the moderator while performing the tasks. Altogether, all tasks were completed by 100% of the participants, and the success rate (pass criteria) was 100% per each task scenario.

In addition, in the follow up satisfaction questionnaire, filled by 18 of the 20 users, all participants (18) commented that the device usage is easy and clear with an average result of 4.4±0.2, using a 1-5 discrete scale (when 1 represents worst and 5 represents best). Labeling and instructions comprehension result was 4.1±0.2 and overall satisfaction was at 4.1±0.2. Two participants found the device to be somewhat heavy and a single user found the trigger less mode to be unnecessary.

These two demonstrate that the intended OTC users can understand the package labeling, correctly choose the device and use it for the indicated aesthetic use, based solely on reading the lableling materials.

#### CLINICAL PERFORMANCE DATA 8.

No new clinical performance data is reported in this submission.

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| Home Well Trading Ltd | Omar Hodge Building, Road Town,<br>Virging Island (British) VG 1110 | |
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| Beurer IPL 8500 device - 510K submission | | RD-18043 A0 |

#### 9. SUBSTANTIAL EQUIVALENCE

Beurer IPL 8500 device by Home Well Trading Ltd. is substantially equivalent to the selected predicate devices in terms of indication for use, technology, performance, areas of usage, patient population and nature of body contact.

The Substantial equivalence decision was based on the following comparison with the predicate devices:

The design and components in the Beurer IPL 8500 device, including the hand-held applicator (with lamp, microcontroller, fan, skin color and proximity sensors, indicator LEDs and operational button/s), are similar to the design and components found in the predicate devices (K161089 and K172791). The performance specifications (including light energy power, wavelength and pulse duration) are identical. The safety features found in the devices are the same, including the skin color sensor, skin proximity sensor, etc. These safety features in the Beurer IPL 8500 device are substantially equivalent to the safety features found in the predicate devices. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new Beurer IPL 8500 device underwent performance testing, including software validation testing and electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2.

#### 10. CONCLUSIONS

The evaluation of our device performances and comparison to the predicate devices demonstrate that it is as safe and as effective as the predicate devices.