(72 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is purely functional.
No.
The device is intended for the removal of unwanted hair, which is generally considered a cosmetic procedure, not a therapeutic one aimed at treating a disease, injury, or medical condition.
No
The device is described as a hair removal system, which is a therapeutic rather than a diagnostic function. Its intended use is for "removal of unwanted hair" and there is no mention of it identifying or assessing any medical condition.
No
The device description explicitly states it is composed of a base unit and hand held applicator, indicating hardware components are included.
Based on the provided information, the Flash N' Go device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "removal of unwanted hair." This is a physical or cosmetic procedure performed on the body, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description of a base unit and hand-held applicator is consistent with a device used for applying energy to the skin for hair removal.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Flash N' Go's function falls outside of this definition.
N/A
Intended Use / Indications for Use
The Flash N' Go is intended for removal of unwanted hair.
The Flash N' Go is an over the counter device intended for the removal of unwanted hair.
Product codes
GEX
Device Description
The Flash N' Go hair removal system is composed of a base unit and hand held applicator. Details are provided in the chapter 1: Device description, of this submission.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical safety data was collected in a prospective safety study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Kó2298
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Home SkinovationsLtd. Flash N' Go OCT 2 3 71115
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter's information
| Name: | Home Skinovations Ltd. |
|---|---|
| Address: | Apolo building, POB 533, Yokneam 20692, Israel |
| Contact: | Dr. Amir Waldman VP Regulatory Affairs |
Device information
| Trade/Proprietary name: | Flash N' Go |
|---|---|
| Common/Usual name: | Light based hair removal device |
| Classification name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology (21CRF §878.4810) | |
| Product code: | GEX |
Predicate devices
- . ABC hair removal system, (K060839) Palomar Medical Technologies Inc.
- . Spectra hair removal laser system, (K053527). SpectraGenics, Inc.
- . Silk'n, (K072906). Home Skinovations Ltd.
Intended use:
The Flash N' Go is intended for removal of unwanted hair.
Device Description:
The Flash N' Go hair removal system is composed of a base unit and hand held applicator. Details are provided in the chapter 1: Device description, of this submission.
1
Performance & clinical data:
The device complies with the following U.S. Food and Drug Administration performance standards: 21CRF § 1040.10 & 1040.11. Clinical safety data was collected in a prospective safety study.
Substantial Equivalence:
The Flash N' Go system is substantial equivalent to its predicate devices. The data in this 510k submission demonstrate that the Flash N' Go system has identical output as the Silk'n, and shares the similar intended use as other predicate devices. Therefore is substantial equivalent to its predicate devices. Details are provided in chapter 3: Substantial equivalent of this submission.
Based upon an analysis of the overall performance characteristic for the device, Home Skinovations Ltd. believes that no significant differences exit. Therefore the Flash N' go should raise no new issues of safety or effectiveness.
August 10, 2008
Aur Wale
Date
Dr. Amir Waldman, VP Regulatory Affairs Home Skiovations Ltd.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Home Skinovations, Ltd. % Dr. Amir Waldman VP, Regulatory Affairs Apolo Building, P.O. Box 533 Yokneam 20692 Israel
OCT 2 3 2008
Re: K082298 Trade/Device Name: Flash N' Go Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: October 2, 2008 Received: October 6, 2008
Dear Dr. Waldman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Dr. Amir Waldman
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events, (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name____Flash N' Go
Indications For Use:
The Flash N' Go is an over the counter device intended for the removal of unwanted hair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over The Counter Use_X
(Optional Format 1-2-96)
Neil R.P. Ogden for mxm
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number