GLIDE DEVICE

K131870 · Home Skinovations , Ltd. · OHT · Aug 14, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K131870
• Device Name: GLIDE DEVICE
• Applicant: Home Skinovations , Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Aug 14, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Story

Pulsed light hair removal device; uses selective photothermolysis to disable hair growth. Handheld applicator contains lamp, 6 indicator LEDs, temperature sensor, skin proximity sensor, and skin color sensor. Device scans skin tone; prevents pulsing if tone is unsuitable. Operated by consumer in home environment. User applies device to skin; device provides feedback via LEDs. Benefits include long-term hair regrowth reduction. Design integrates all components (microcontroller, fan, sensors, lamp) into single handheld unit, differing from predicate's base-unit architecture.

Clinical Evidence

No clinical data. Bench testing only. Usability study conducted with 20 potential end users in simulated home environment; 100% task completion rate. Software validation and electrical/mechanical safety testing (IEC 60601-1, IEC 60601-1-2) performed.

Technological Characteristics

Pulsed light hair removal; selective photothermolysis. Handheld form factor. Components: lamp, 12V regulator, microcontroller, fan, temperature sensor, skin proximity sensor, skin color sensor, indicator LEDs. Connectivity: standalone. Standards: IEC 60601-1, IEC 60601-1-2, EN 62471, EN 60601-2-57. Software validation per IEC 60601-1-4.

Indications for Use

Indicated for over-the-counter removal of unwanted hair and permanent reduction in hair regrowth in adults. Contraindicated for unsuitable skin tones as detected by integrated sensors.

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)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

K131870

(Premarket Notification [510(k)] Number)

# Applicant Name:

Company Name: Address:

Home Skinovations Ltd. Tavor building, POB 533 Yokneam 20692, ISRAEL Tel: [phone] Fax: [phone] E-mail: [e-mail]

# Contact Person:

AUG 1 4 2013

Official Correspondent: Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. Company Name: Company Address: 20 Hata'as Str., Suite 102 K far Saba 44425 Israel Tel: [phone] Fax: [phone] E-mail: [e-mail] June 18, 2013 Date Prepared: Trade Name: Glide Device Classification Name: CFR Classification section 878.4810; (Product code OHT)

Classification: Class II Medical Device

#### Predicate Device:

The Glide device is substantially equivalent to the previously cleared, Silk'n Flash N Go device, also manufactured by Home Skinovations Ltd.:

| Device | Manufacturer | 510(k) No. |
|-------------------|------------------------|------------|
| Silk'n Flash N Go | Home Skinovations Ltd. | K103184 |

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## Device Description:

The Glide device is a 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 Glide device is composed of a hand held applicator. The device contains 6 LEDs indicated 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm . The device contains a lamp, a temperature sensor, a skin proximity sensor and a skin color sensor to detect appropriate skin tones. The skin sensor scans darker skin tones and will not pulse if the skin tone is not suitable for treatment.

# Intended Use/Indication for Use:

The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

## Performance Standards:

The Glide device has been tested and complies with the following voluntary recognized standards:

- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for . Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995
- . IEC 60601-1-2 (2007), Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility --Requirements and Tests
- EN 62471: 2008 Photobiological safety of lamps and lamp systems .
- EN 60601-2-57: 2011 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.
- Software Validation according to the IEC 60601-1-4 standard and the FDA . Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.

## Non-Clinical (Bench) Performance Data:

The objective of the Usability Study was to test the Glide device usability, i.e., the safe and effective device use, by potential end users, under actual use conditions.

Twenty (20) potential device end users were enrolled in the Usability Study. The Glide device, in its original packaging, along with the user manual and QuickStart guide was provided to the patient in a simulated home use environment. The patient labeling was in the format intended for distribution. All subjects were provided with a pre-test and post-test questionnaire and a list of tasks to complete, including applying and operating the device.

All of the 20 enrolled subjects (100%) completed all tasks successfully. The Glide device, in its

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original packaging, along with the user manual and QuickStart guide, can be used safely and effectively by potential end users, under actual use conditions.

### Clinical Performance Data:

Not applicable.

#### Substantial Equivalence:

The indications for use and technological characteristics of the Glide device are substantially equivalent to the indications for use and technological characteristics of the Silk'n Flash N Go device.

The design and components in the Glide device, including the hand piece applicator (with 12V regulator, lamp, microcontroller, fan, temperature sensor, skin proximity sensor, indicator LEDs and operational button/s} are similar to the design and components found in the predicate Silk'n Flash N Go device, although in the predicate device these components are found in either the hand piece applicator or the base unit and in the Glide device all components are in the hand piece applicator. The performance specifications (including light energy power, wavelength and pulse duration) in all the devices are identical. The safety features found in all the devices are the same, including the system self-check, temperature sensor, skin color sensor, skin proximity sensor, etc. These safety features in the Glide device are substantially equivalent to the safety features found in the predicate device. Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns. Furthermore, the new Glide 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 (provided in Section 12). Usability testing was also conducted due to the design changes in the operational buttons and indicator LEDs in the Glide device and the results are presented in Section 12, as well. These performance tests demonstrate that the minor differences in the device software and design meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the Glide device is substantially equivalent to the predicate Silk'n Flash N Go device, cleared under 510(k) K103184 and therefore, may be legally marketed in the USA.

#### Conclusions:

Based on the performance testing and comparison to the predicate device, the Glide device is substantially equivalent to the Silk'n Flash N Go predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Regulatory Affairs Consulting Ltd. % Ahava Stein 20 Hata'as Street., Suite 102 Kfar Saba, Israel 44425

August 14, 2013

Re: K131870

Trade/Device Name: Glide 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, 2013 Received: August 8, 2013

Dear Ms. Stein:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ahava Stein

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FOR

Peter D. Rumm -S.

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K131870

Device Name: Glide Device

# Intended Use Statement:

The Glide™ device is an over the counter device intended for the removal of unwanted hair. The Glide™ device is also intended for permanent reduction in hair regrowth, defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Prescription Use (Per 21 C.F.R. 801 Subpart D) OR

Over-The-Counter Use V (Optional Format Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.08.13 15:28:14 -04'00' (Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K131870