(104 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is purely hardware-based.
Yes.
The device is intended for the removal of unwanted hair using selective photothermal treatment, which is a therapeutic purpose.
No
The document describes the device's intended use as hair removal, not diagnosis of a disease or condition.
No
The device description explicitly states it is composed of a base unit and hand held applicator, indicating it includes hardware components.
Based on the provided information, the Silk'n device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "removal of unwanted hair by using selective photothermal treatment." This is a therapeutic or cosmetic application, not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The description of a base unit and hand-held applicator aligns with a device used directly on the body for treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Silk'n device's function is to physically remove hair using light energy.
N/A
Intended Use / Indications for Use
The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Silk'n 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
under the direction of a physician, after training by a healthcare professional.
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 clinical study to support the safety and effectiveness of the Silk'n hair removal device. The clinical studies demonstrated that the Silk'n system functions as intended with no adverse events.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 EFFECTI Home SkinovationsLtd. Silk'n
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
2008
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 |
|---|---|
| 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.
- . SpaTouch Photoepilation system, (K020856) Radiancy Ltd.
Intended use:
The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.
Device Description:
The Silk'n 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.
Performance & clinical data:
1
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 clinical study to support the safety and effectiveness of the Silk'n hair removal device. The clinical studies demonstrated that the Silk'n system functions as intended with no adverse events.
Substantial Equivalence:
The Silk'n system is substantial equivalent to its predicate devices. The data in this 510k submission demonstrate that the Silk'n system shares the same intended use and similar overall characteristic, 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 Silk'n should raise no new issues of safety or effectiveness.
January 11, 2008
Date
Kür Walde
Dr. Amir Waldman, VP Regulatory Affairs Home Skiovations 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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.
JAN 2 3 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Home Skinovations, Ltd. % Dr. Amir Waldman VP Regulatory Affairs Apolo Building, POB 533 Yokneam 20692 Israel
Re: K072906 Trade/Device Name: Silk'n Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 11, 2008 Received: January 17, 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 Prestmarket, 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. Milherson
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___________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over The Counter Use__________________________________________________________________________________________________________________________________________________________
Mark A. Millhem
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative,
and Neurological Devices
510(k) Number