(12 days)
Not Found
No
The summary describes a pulsed light hair removal system and does not mention any AI or ML components or capabilities.
No
The device is intended for hair removal and permanent hair regrowth reduction, which are cosmetic purposes rather than for treating or diagnosing a disease or condition.
No
The device is described as an "over the counter device intended for the removal of unwanted hair" with a "permanent reduction in hair regrowth." This indicates a cosmetic or therapeutic purpose (hair removal), not a diagnostic one (identifying a disease or condition).
No
The device description explicitly states it is a "pulsed light system composed of a base unit and hand held applicator," indicating it includes hardware components.
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 for the removal of unwanted hair and permanent reduction in hair regrowth. This is a physical treatment applied to the body, not a test performed on biological samples (like blood, urine, tissue, etc.) to diagnose or monitor a medical condition.
- Device Description: The device is described as a pulsed light system with a base unit and hand-held applicator. This aligns with a physical treatment device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVDs.
Therefore, the Flash N Go device, as described, falls under the category of a therapeutic or cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flash N Go device is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
Product codes
GEX, OHT
Device Description
The Flash N Go hair removal system is a pulsed light system composed of a base unit and hand held applicator.
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 Use
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 data was collected in a prospective multisite clinical study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Flash N Go (K082298), TRIA Laser Hair Removal System (K090820), EpiLight and PhotoDerm HR (K991935)
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Home Skinovations Ltd. Silk'n Flash N Go
NOV 1 0 2010
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: | Silk'n 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
- Flash N Go (K082298), by Home Skinovations Ltd. .
- TRIA Laser Hair Removal System (K090820),by Tria Beauty, Inc. .
- EpiLight and PhotoDerm HR (K991935), by ESC Medical system Inc. �
Intended use:
The Flash N Go device is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
Device Description:
The Flash N Go hair removal system is a pulsed light system composed of a base unit and hand held applicator.
Performance data:
The device complies with the following U.S. Food and Drug Administration performance standards: 21CRF § 1040.10 & 1040.11. Clinical data was collected in a prospective multisite clinical study.
1
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 is identical to the cleared Flash N' Go, and shares the same intended use as other predicate devices. Therefore is substantial equivalent to its predicate devices. Details are provided in Substantial equivalent section 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 Silk'n Flash N Go should raise no new issues of safety or effectiveness.
October 21, 2010
huis, wdu
Date
Dr. Amir Waldman, VP Regulatory Affairs Home Skinovations Ltd.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its head, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Home Skinovations Ltd. % Dr. Amir Waldman Vice President, Regulatory Affairs Apolo Building, P.O. Box 533 Yokneam 20692, Israel
NOV 1 0 2010
Re: K103184
Trade/Device Name: Silk'n Flash N Go 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 21, 2010 Received: October 29, 2010
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. 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.
3
Page 2 - Dr. Amir Waldman
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours,
D.V. or
Mark N. Melkerse Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known)_KlO3184
Device Name_ Flash N Go
Indications For Use:
NOV 1 0 2010
Flash N Go is an over the counter device intended for the removal of unwanted hair.
Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.
(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
Neil RE Oden Gar mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103184
(Optional Format 1-2-96)