The Beurer 5500 IPL Device is an over the counter device intended for the removal of unwanted body and/ or facial hair in adults. The Beurer 5500 IPL 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.

Device Description

The Beurer IPL 5500 device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The Beurer IPL 5500 device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Beurer IPL 5500 device is 3 cm². The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the Beurer IPL 5500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the Beurer IPL 5500 device will not trigger a pulse.

AI/ML Overview

This document is a 510(k) premarket notification for the Beurer IPL 5500 hair removal device. It aims to demonstrate substantial equivalence to previously cleared devices. It does not contain the detailed information typically found in a clinical study report that would directly address acceptance criteria, human reader performance, or specific ground truth methodologies in the way an AI/ML device submission would.

Therefore, many of the requested items (e.g., number of experts, adjudication methods, MRMC study, training set details) are not applicable to this type of submission for a non-AI/ML medical device. The focus here is on demonstrating safety and efficacy through equivalence to existing devices and compliance with recognized standards.

Here's an analysis of what information can be extracted relevant to the spirit of your questions, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" for clinical performance in the way an AI/ML device would, because it's relying on substantial equivalence to predicate devices, not demonstrating novel clinical efficacy through a new study with specific performance metrics.

Instead, the "performance" is demonstrated through:

Technological Characteristics Comparison (Section 6): Showing that the Beurer IPL 5500 device operates on the same principles and largely the same parameters as predicate devices.
- Wavelength: Beurer IPL 5500 (475-1200nm) vs. sensiLight mini (475-1200nm) vs. Duo (480-1200nm). Acceptance: Same or very similar spectrum. Performance: Met.
- Fluence/Flux: Beurer IPL 5500 (5 J/cm²) vs. predicate devices (5 J/cm²). Acceptance: Exactly the same maximum energy. Performance: Met.
- Pulse Duration: Beurer IPL 5500 (same as sensiLight mini, similar to Duo). Acceptance: Same/similar. Performance: Met.
Bench and Safety Testing (Section 7): Compliance with recognized standards.
- Acceptance: Compliance with various IEC, ISO, and FCC standards.
- Performance: The document states "has been successfully tested through bench and safety tests" and "complies with the following voluntary recognized standards." Specific results/values are not provided in this summary, but the claim is that they met the standards.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable. This submission does not describe a new clinical study with a "test set" of patients for performance evaluation in the way an AI/ML device would. It relies on the prior clearance of predicate devices and bench testing.
Data Provenance: Not applicable for a new clinical study. The "data" driving the clearance is the established safety and efficacy of the predicate devices and the results of bench tests on the new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There was no new clinical study with a "test set" requiring ground truth establishment by experts for performance assessment.

4. Adjudication Method for the Test Set:

Not applicable. There was no new clinical study with a "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done & Effect Size:

No. This is not an AI/ML device, and no MRMC study was performed or needed for this type of 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used:

For the intended use and clinical claims (permanent hair reduction), the "ground truth" for predicate devices would have been clinical outcomes data (measured hair reduction at 6, 9, 12 months).
For the current device's submission, the "ground truth" for demonstrating safety and equivalence is bench test results following established engineering and medical device standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device using a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/ML device.

Summary of what's present in the document:

The submission focuses heavily on substantial equivalence to predicate devices (EL Global Trade Ltd.'s sensiLight Mini and Stetic Medical Aesthetics Development's Duo IPL-HH380-IT) based on:

Similar indications for use (hair removal, permanent hair reduction).
Same technology (Intense Pulsed Light - IPL).
Comparable technological characteristics (wavelength spectrum, fluence/flux, pulse duration).
Similar design and components.
Identical safety features (skin proximity sensor, skin pigmentation sensor).
Extensive bench and safety testing to recognized standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-57, FCC part 15, IEC 60601-1-2, IEC 62471, IEC 62304 for software, ISO 10993-1 for biocompatibility, ISO/IEC 14971 for risk management). The document states "Tests results are supporting all labeling claims in order to establish substantial equivalency."

"No new clinical performance data is reported in this submission" (Section 8) explicitly states that the submission did not conduct a new clinical study to directly prove efficacy, but rather relied on the equivalence to devices that already demonstrated it.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 28, 2018

Home Well Trading LTD Martin Gurovich VP R&d Omar Hodge Building, Road Town Tortola, 1110 Vg

Re: K181121

Trade/Device Name: Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin 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: April 26, 2018 Received: April 30, 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. 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 misl eading.

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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -53 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181121

Device Name Beurer 5500 IPL Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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Home Well Trading Ltd

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

Beurer IPL 5500 device – 510K submission

RD-19054 A0

510(K) SUMMARY FOR HOME WELL TRADING LTD.'S BEURER IPL 5500 DEVICE

DATE PREPARED: APRIL 26™, 2017

1. 510(K) OWNER NAME

Home Well Trading Ltd. Omar Hodge Building, Tortola, British Virgin Islands Phone: (213) 335-3521.

Contact person name: Martin Gurovich, VP R&D Phone: (213) 335-3521, E mail: ra_qa@homewellt.com

2. DEVICE NAME

Common/Usual Name: Light based hair removal devices Proprietary/Trade name: Beurer IPL 5500 device or IPL 5000 or PureSkin Pro Classification: Beurer IPL 5500 device by Home Well Trading Ltd. has been classified as Class II device under the following classification names:

Classification Name	Product Code	Regulation Number	Panel
Light Based Over-The-Counter Hair RemovalandPowered Light BasedNon-Laser SurgicalInstrument With ThermalEffect	OHTandONF	878.4810	General and PlasticSurgery

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3. PREDICATE DEVICES

Beurer IPL 5500 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 at July 8, 2016 and K140527 at July 31, 2014.
3.2 Stetic Medical Aesthetics Development (Shenzhen) Co. Ltd.'s Duo model: IPL-HH380-IT,
cleared under 510(k) number K161565 at September 1, 2016.

4. DEVICE DESCRIPTION

The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the Beurer IPL 5500 device is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the Beurer IPL 5500 device 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.

5. INTENDED USE

The Beurer IPL 5500 device is an over the counter device intended for removal of unwanted body and/or facial hair in adults. The Beurer IPL 5500 device is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as a long-

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Beurer IPL 5500 device – 510K submission

term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Beurer IPL 5500 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 5500 device and the predicate devices utilize the same spectrum (475 - 1200nm for both Beurer IPL 5500 device and sensiLight mini predicate device and 480-1200nm for the Duo predicate device).
Fluence/flux defines the energy per area (e.g. joules per cm²) for the treatment. The . Beurer IPL 5500 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 5500 device and the predicate device sensiLight mini utilize exactly the same pulse and similar to the Duo predicate device.

7. PERFORMANCE DATA (BENCH)

Beurer IPL 5500 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 5500 device has been tested and complies with the following voluntary recognized standards:

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Beurer IPL 5500 device – 510K submission

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.
1. 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.
1. 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.
1. FCC part 15, Subpart B, Class B.
1. 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.
1. IEC 62471:2006 (Ed. 1). Photo-biological safety of lamps and lamp systems.
1. 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.
1. 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).
1. ISO/IEC 14971:2007 (BS EN ISO 14971:2012) Medical devices Application of risk management to medical devices.

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

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8. CLINICAL PERFORMANCE DATA

No new clinical performance data is reported in this submission.

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Home Well Trading Ltd	Omar Hodge Building, Road Town,Virgin Island (British) VG 1110
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Beurer IPL 5500 device – 510K submission

RD-19054 A0

9. SUBSTANTIAL EQUIVALENCE

Beurer IPL 5500 device by Home Well Trading Ltd. is substantially equivalent to the predicate devices selected in terms of indication for use, technology, performances, place of use, patient population and nature of body contact.

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

The design and components in the Beurer IPL 5500 device, including the hand held applicator (with lamp, microcontroller, fan, skin color sensor, skin proximity sensor, indicator LEDs and operational button/s) are similar to the design and components found in the predicate devices (K161089 and K161565). The performance specifications (including light energy power, wavelength and pulse duration) are identical or similar. 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 5500 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 5500 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 predicate devices demonstrate that it is as safe and as effective as the predicate devices.

Regulation Number and Section

§ 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.