GLIDE DEVICE

K141242 · Home Skinovations , Ltd. · OHT · Oct 17, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141242
• Device Name: GLIDE DEVICE
• Applicant: Home Skinovations , Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• 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 long-term, 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

Glide device is a handheld pulsed light hair removal system; utilizes selective photothermolysis to disable hair growth. Device incorporates lamp, temperature sensor, skin proximity sensor, and skin color sensor to ensure safety; prevents pulsing on unsuitable skin tones. User interface includes 6 LEDs indicating 5 energy levels and device status. Intended for over-the-counter use; operator performs self-treatment. Output is optical energy delivered to skin via 2.7cm2 spot size. Clinical benefit is long-term, stable reduction in hair regrowth.

Clinical Evidence

Prospective clinical study evaluated hair removal from facial skin (below cheekbone line). Follow-up durations were 1 and 3 months post-treatment. No adverse events were reported.

Technological Characteristics

Handheld pulsed light device; 2.7cm2 spot size; 5 energy levels. Features integrated temperature, skin proximity, and skin color sensors for safety. Operates via selective photothermolysis. No new performance standards cited.

Indications for Use

Indicated for removal of unwanted hair and permanent reduction in hair regrowth in individuals suitable for light-based treatment, as determined by integrated skin color 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

• Glide device (K131870)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem.

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

October 21, 2014

Home Skinovations Ltd. Ms. Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Street, Suite 102 Kfar Saba 44425, Israel

Re: K141242 Trade/Device Name: Home Skinovations 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, ONF Dated: August 19, 2014 Received: September 3, 2014

Dear Ms. Stein:

This letter corrects our substantially equivalent letter of December 17, 2014.

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

{1}------------------------------------------------

Page 2 - Ahava Stein

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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,

## David Krause -S

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

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141242

Device Name Glide Device

Indications for Use (Describe)

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 long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

{3}------------------------------------------------

Section 5:

# 510(k) Summary

: ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・

:

{4}------------------------------------------------

## 510(K) SUMMARY HOME SKINOVATIONS GLIDE DEVICE

## 510(k) Number K141242

## Applicant Name:

| Company Name: | Home Skinovations Ltd. |
|---------------|-----------------------------|
| Address: | Tavor Building, POB 533 |
| | Yokneam 20692, Israel |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |

## Contact Person:

| Official Correspondent: | Ahava Stein |
|-------------------------|---------------------------------------------------------------------------------------------|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | 20 Hata'as Str., Suite 102<br>Kfar Saba 44425<br>Israel |
| Tel: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Date Prepared: | May 8, 2014 |
| Trade Name: | Glide Device |
| Classification Name: | CFR Classification section 878.4810; (Primary Product Code OHT, Secondary Product Code ONF) |
| Classification: | Class II Medical Device |

## Predicate Device:

The Glide device is substantially equivalent to the following predicate devices.

| . Manufacturer | 001/100 | 210/1-1 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------|
| t<br>AMA<br>----------------------------------------------------------------------------------------------------<br>--------------------------<br>Comment Color Coll Coll . I | | 17100 |

{5}------------------------------------------------

## 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 indicating 5 different energy levels and other device functions. The spot size in the Glide device is 2.7cm2. 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 long-term, 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:

No new standards have been cited for this submission.

## Non-Clinical (Bench) Performance Data:

The Glide device is identical in all details to the Glide device cleared under K131870. No new non-clinical performance data is reported in this submission.

## Clinical Performance Data:

The Glide device was evaluated in a prospective clinical study for the intended use of hair removal. The study evaluated hair removal from facial skin (below cheekbone line), for follow up durations of 1 and 3 months after completion of the last treatment. No adverse events related to the treatment were reported.

#### Substantial Equivalence:

The Glide device is identical to the Glide device previously cleared under K131870. The indications for use and technological characteristics of the Glide device are substantially equivalent to the indications for use and technological characteristics of the previously cleared Glide device.

Consequently, it can be concluded that the Glide device is substantially equivalent to the predicate Glide device, cleared under 510(k) K131870, and therefore, may be legally marketed in the USA.

#### Conclusions:

Based on the performance testing and comparison to predicate devices, the Glide device is substantially equivalent to the previously cleared Glide predicate device.