Lumilisse IPL Hair Remover

K172791 · Conair Corporation · OHT · Jan 18, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172791
• Device Name: Lumilisse IPL Hair Remover
• Applicant: Conair Corporation
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Jan 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.

Device Story

The Lumilisse IPL Hair Remover is an over-the-counter, handheld intense pulsed light (IPL) system for home use. It utilizes a quartz light tube to emit pulses of light to remove unwanted hair. The device incorporates a skin color sensor system that automatically regulates light intensity based on detected skin tone, and a capacitance-based skin contact sensor that prevents flashing unless the port is fully covered by skin. It features five intensity levels. The user operates the device by applying the handset to the skin; the device provides light pulses at varying repetition rates depending on the intensity level. The output is intended to reduce hair density and amount. Clinical efficacy is evaluated by the user through observation of hair reduction over time. The device is designed for self-use by adults to achieve hair removal in various body areas.

Clinical Evidence

Clinical study conducted on European precursor units (G920/G930) evaluated in-vivo efficacy and cutaneous acceptability on legs, underarms, and upper lips. Results showed significant reduction in hair amount and density. Over 75% hair reduction on legs was maintained for 6 months. Cutaneous acceptability was positive with no device-related safety events. Usability study with 20 participants confirmed ability to correctly use the device per instructions.

Technological Characteristics

IPL system; 550-1200 nm (body) / 600-1200 nm (facial) wavelengths; 2.0-4.5 J/cm² intensity; capacitance-based skin contact sensor; skin tone sensor; 100-240 VAC power; IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-57, and IEC 62471 compliant.

Indications for Use

Indicated for removal of unwanted hair in men and women aged 21 and older. Suitable for body (legs, arms), underarms, bikini line, and lower half of face (below cheekbones).

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

• Silk'n Flash N Go (K103184)

Reference Devices

• mē (K131649)
• iPulse Smoothskin Gold (K160968)

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, 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.

January 18, 2018

Conair Corporation % Mr. E.J. Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114

Re: K172791

Trade/Device Name: Lumilisse IPL Hair Remover 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: October 20, 2017 Received: October 20, 2017

Dear Mr. Smith:

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 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); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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, Jennifer R. Stevenson -ડર્ 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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#### Indications for Use

510(k) Number (if known) K172791

Device Name Lumilisse Hair Removal System

Indications for Use (Describe)

The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.

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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# 510(k) Summary

| Sponsor: | Conair Corporation |
|-----------------------------|--------------------------------------------------------|
| Address: | One Cummings Point Road<br>Stamford, CT 06902 |
| Telephone Number: | 203-975-4617 |
| Contact Person: | Mike Cantrell<br>Regulatory Compliance |
| Email: | [e-mail] |
| Summary Preparation Date: | January 18, 2018 |
| Device Name: | |
| Classification Name: | Light based OTC Hair Remover |
| Common/Usual Name: | Light based OTC Hair Remover |
| Proprietary Name: | Lumilisse IPL Hair Remover |
| Establishment Registration: | 1222304 |
| Classification: | Class II |
| Product Code: | OHT |
| Code of Federal regulation: | 21 CFR 878.4810 |
| Review Panel: | General Surgery Devices Branch One - Light Based/Laser |

## Predicate Device:

| Predicate | Manufacturer | Brand Name | 510(k) Number |
|-----------|------------------------|---------------------------|---------------|
| Primary | Home Skinovations Ltd. | Silk'n Flash N Go | K103184 |
| Reference | Syneron Beauty Ltd. | mē | K131649 |
| Reference | CyDen Ltd. | iPulse Smoothskin<br>Gold | K160968 |

# Device Description:

The Lumilisse IPL Hair Remover (Figure 11.1) is a hair-removal device that eliminates unwanted hair from the body (legs and arms), and from more sensitive areas (underarms, bikini line, lower half of the face - below the cheekbones) using intense pulse light technology.

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The Lumilisse IPL Hair Remover is an Intense Pulsed Light (IPL) system consisting of:

- . Handset - contained within the handset is the High Voltage Capacitor, Capacitor Charger, Control Electronics and Firmware, Quartz Light Tube, Cooling System, Skin Tone and Skin Contact Sensors and the firmware for operation and safety.
- External Power Supply – used to convert the electricity from the mains supply (either 110V or 230V, 50/60Hz) to a much lower DC value. This power supply unit is an "off-theshelf" component which meets all the relevant electrical safety standards.
- Skin Color Sensor System - For effective and safe treatment, the Lumilisse IPL Hair Remover is equipped with the Skin Sensor System, a skin color detection system that automatically regulates the light intensity applied to the skin.
- . Levels of Intensity - The Lumilisse IPL Hair Remover features 5 levels of intensity, running from the lowest (level 1) to the highest (level of intensity indicates the intensity of the pulsed light applied to the skin when using the Lumilisse Hair Remover.

The Lumilisse Hair Remover can be used by men and women aged 21 and older.

## Device Indications for Use:

The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted hair.

#### Discussion of Technological Characteristics:

#### Discussion of Similarities

The Lumilisse IPL Hair Remover and the predicate devices have IPL technology, capacitancebased skin contact sensor such that if the flash port is not in direct contact with the skin (covering the entire port) the unit will not flash, skin tone sensors, pulse durations for use, use environment, user group, power source, operating/storage temperature and relative humidity conditions. The Lumilisse IPL Hair Remover has the identical wavelengths as the mē.

#### Discussion of Differences K103184:

The Lumilisse IPL Hair Remover lowest light intensity reading is 2.0 J/cm² versus predicate's lowest light intensity of 3.0 - 5.0 J/cm² and the Lumilisse IPL Hair Remover wavelength range is 550 nm - 1200 nm versus the predicate device wavelength range of 475 nm - 1200 nm. The differences in light intensity and wavelength raise no new issues of safety and effectiveness.

#### Discussion of Differences K131649:

The Lumilisse IPL Hair Remover maximum light intensity is 4.5 J/cm² versus the predicate's maximum light intensity of 4 J/cm² and the difference raises no new issues of safety and effectiveness.

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#### Discussion K160968:

The Lumilisse IPL Hair Remover has a wavelength of 550-1200m and the predicate has a wavelength of 510-1100nm. The Lumilisse IPL Hair Remover has a light intensity of 2.0 J/cm² and the predicate has a maximum optical of 3-6 J/cm². The Lumilisse IPL Hair Remover automatically controls the repetition rate for Level 1.6 seconds and Level 5, 1 pulse every 3.5 seconds, whereas, the predicate states their repetition rate as manually, 1 pulse every 1-2 seconds. The differences in wavelength, light intensive no new issues of safety and effectiveness.

| Parameters | Conair<br>Lumilisse IPL Hair<br>Remover | Home Skinovations<br>Ltd<br>Silk'n Flash N Go | Syneron Beauty Ltd.<br>mē | CyDen Ltd | Comments |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 510 (k) Number4 | The Lumilisse IPL<br>(Intense Pulsed<br>Light) Hair<br>Remover is an<br>over-the-counter<br>device<br>intended for the<br>removal of<br>unwanted hair. | K103184<br>Flash N Go is an<br>over the counter<br>device intended for<br>the removal of<br>unwanted hair.<br>Flash N Go is also<br>intended for<br>permanent<br>reduction in hair<br>regrowth defined<br>as long-term,<br>stable reduction in<br>hair counts<br>following a<br>treatment regime. | K131649<br>The mē Is an over-the-<br>counter device<br>Intended for the<br>removal of unwanted<br>hair. Mē Is also<br>Intended for<br>permanent reduction<br>In hair growth<br>following an Initial<br>treatment regimen<br>with or without<br>maintenance when<br>measured at 6, 9, and<br>12 months. | K160968<br>The iPulse<br>SmoothSkin Gold<br>Hair Removal System<br>is indicated for the<br>removal of<br>unwanted hair. The<br>iPulse Smoothskin<br>Gold is also indicated<br>for the permanent<br>reduction in hair<br>regrowth, defined as<br>the long-term, stable<br>reduction in the<br>number<br>of hairs regrowing<br>when measured at 6,<br>9 and 12 months<br>after the completion<br>of a<br>treatment regime. | Substantially<br>Equivalent |
| Indications for Use | | | | | |
| Use Environment | Home Use | Home Use | Home Use | Home Use | Substantially |
| | | | | | Equivalent |
| Wavelength | 550-1200 nm<br>(when using with<br>body lens)<br>600-1200 nm<br>(when using with<br>facial lens) | 475-1200 nm | 550-1200 nm | 510-1100nm | Different |
| Light Intensity | Level 1: 2.0 J/cm²<br>Level 2: 3.0 J/cm²<br>Level 3: 3.5 J/cm²<br>Level 4: 4.0 J/cm²<br>Level 5: 4.5 J/cm² | Level 1: 3-5 J/cm² | Maximum Optical<br>= 4 J/cm² | 3 - 6 J/cm² | Different |
| Repetition Rate | At Level 1, 1 pulse<br>every 1.6 seconds<br><br>At Level 5, 1 pulse<br>every 3.5 seconds | 1 pulse every 3.5 seconds | 1 pulse every 0.9 seconds | Manually, 1 pulse<br>every 1-2 seconds | Different |
| Power Source | 100-240 VAC, 3.5 A | 100-240V, 2A | 100-240 VAC, 50-60 Hz | 110V or 230V,<br>50/60Hz | Substantially<br>Equivalent |
| | | Temperature | | | |
| Operating | +10°C to +35°C | 10°C to 40°C | 10°C - 30° | 15°C - 30°C | Substantially |
| Storage | -40°C to +70°C | -40°C to +70°C | 10°C - 55°C | 85% non-condensing | Equivalent |
| | | Humidity | | | |
| Operating | 30% to 75% RH | 30% to 75% RH | Up to 80% at 37°C | N/A | Substantially |
| Storage | 30% to 75% RH | 30% to 90% RH | 90% at 55°C | N/A | Equivalent |
| | | Atmospheric Pressure | | | |
| Operating | 700 to 1060hPa | 700 to 1060hPa | 700-1060hPa | N/A | Substantially<br>Equivalent |

Predicate Product Comparison Table

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#### Non-clinical Performance Data:

- ISO 10993-5 Biological Evaluation of Medical Devices – Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin ● Sensitization
- . 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 Compatibility -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 60601-2-57 Medical electrical equipment - part 2-57: particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
- IEC 62471 Photobiological safety of lamps and lamp systems
- FCC Subpart 15B Unintentional Radiators
- . ISO 14971 Medical Devices – Applications of Risk Management to Medical Devices
- Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "Moderate" level of concern.

#### Usability Study

A Human Factors Usability study was conducted using 20 participants to demonstrate the participants were capable of reading the instruction manual and were then able to use the Lumilisse IPL Hair Remover correctly. The Conair Lumilisse IPL Hair Remover was found to be safe and effective for the intended users, uses and use environments based on the results of our simulated use study, biocompatibility testing,

#### Clinical Study:

A clinical study was conducted comparing the G920 and G930 IPL Hair Remover (European pre-cursor to the IPL960F Lumilisse Hair Remover) hand-held systems to evaluate the in-vivo efficacy and cutaneous acceptability on the legs and cutaneous acceptability for the underarms and half-upper lips.

Each of the two units had a significant effect in lowering the amount and density of hairs in regions tested. The only safety events appear to be unrelated to the units, themselves. The dermatological evaluation was positive for safety, and the final study results, for the large majority of the test Subjects, was that the units had the desired effects.

The comparative study concluded the Lumilisse Hair Remover reduction results last for 6 months with over 75% less hair on legs and concluded cutaneous acceptability for legs, underarms and half-upper lip.

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The study concluded Lumilisse Hair Removal Systems as safe and effective when used according to instructions.

## Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Conair concludes that the Lumilisse IPL Hair Removal System is substantially equivalent to predicate devices with regard to safety and effectiveness.