(51 days)
Not Found
No
The device description details sensors and logic for skin tone detection and safety, but there is no mention of AI or ML algorithms being used for these functions or any other aspect of the device's operation.
No.
The intended use is for the removal of unwanted hair and permanent reduction in hair regrowth, which are cosmetic purposes, not for treating a disease or condition.
No
The device is intended for hair removal and reduction, which is a treatment, not a diagnostic purpose. While it has sensors to ensure safe operation by detecting skin tone, these are for operational safety rather than diagnosing a medical condition.
No
The device description explicitly states it is a "pulsed light hair removal device" composed of a "hand held applicator" containing LEDs, a lamp, and various sensors (temperature, skin proximity, skin color). This indicates a physical hardware device, not a software-only one.
Based on the provided information, the Glide™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent reduction in hair regrowth. This is a cosmetic/aesthetic purpose, not a diagnostic one.
- Device Description: The device uses pulsed light to target hair follicles. It does not analyze biological samples (like blood, urine, or tissue) to diagnose a condition or provide information about a person's health status.
- Lack of Diagnostic Function: The device's sensors (temperature, skin proximity, skin color) are for safety and proper operation during the hair removal process, not for diagnosing any medical condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Glide™ device does not fit this description.
N/A
Intended Use / Indications 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.
Product codes
OHT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over the counter device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 original packaging, along with the user manual and QuickStart guide, can be used safely and effectively by potential end users, under actual use conditions.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
(Premarket Notification [510(k)] Number)
Applicant Name:
Company Name: Address:
Home Skinovations Ltd. Tavor building, POB 533 Yokneam 20692, ISRAEL Tel: +972(4)9097470 Fax: +972(4)9097471 E-mail: ahava@asteinrac.com
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: +972-9-7670002 Fax: +972-9-7668534 E-mail: ahava@asteinrac.com 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 |
1
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
2
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.
3
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
4
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
5
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)
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