(66 days)
Not Found
Not Found
No
The device description focuses on the physical mechanism of radio frequency energy delivery via tweezers and does not mention any computational or learning components. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as being for "the removal of hair," and its mechanism of action is to destroy the hair papilla to prevent hair growth. This function is aesthetic rather than therapeutic, as it does not treat a disease, injury, or other medical condition.
No
The device is used for hair removal by destroying the hair papilla, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it works by emitting radio frequency energy from tweezer tips, indicating a hardware component is essential to its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The described device works by applying radio frequency energy directly to hair follicles on the body for hair removal. It does not analyze any biological specimens taken from the body.
Therefore, based on the provided information, this device falls under the category of a therapeutic or cosmetic device, not an IVD.
N/A
Intended Use / Indications for Use
For the removal of hair
Product codes
KCX
Device Description
The device works by emitting from the tweezer tips radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result that the hair does not grow back. More than one treatment may be necessary.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5360 Tweezer-type epilator.
(a)
Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.(b)
Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
K973179
510 (k) SUMMARY
Trade name:
Feminique™ Sonic Hair Remover
Global TV Concepts Ltd. Marketed by: 776 South Military Trail Deerfield Beach, Florida 33442 (954) 570-9998; fax (954) 570-9990 Ms. Laurie Braden Contact:
Date prepared: August 22, 1997
Sonic hair remover Common name :
Classification Tweezer-type epilator (per 21 C.F.R. § 878.5360) name :
Hair removal Intended use:
The device works by emitting from the tweezer tips Description: radio frequency energy that is transmitted down an individual hair grasped by the tweezers to the root and papilla of the hair. The tweezers may also be used to slide the hair out after treatment. The radio frequency energy destroys the papilla, with the result More than one that the hair does not grow back. treatment may be necessary.
Substantial equivalence :
The device is substantially equivalent to the IGIÁ Hair Removal System, another tweezer-type Both devices emit a 27 MHz radio frequency epilator. signal, with a peak reading of dBuV 107.15 for the Feminique™ and dBuV 105.6 for the IGIÁ. The principal difference between the products is that the Feminique™ Sonic Hair Remover relies on 4 "AAA" batteries for its operation, whereas the IGIA Hair Removal System uses household electrical energy. Also the Feminique™ uses 6V of electricity to generate the radio frequency signal, whereas the IGIÁ uses 9V.
The safety and efficacy of tweezer-type epilators are discussed in the attached Federal Register notice published by the Food and Drug Administration (FDA) on June 11, 1997, 62 Fed. Reg. 31771-775.
Attachment
OCT 3.0 1997
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Global TV Concepts, Ltd. ·c/o Ms. Samia N. Rodriguez Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, NW, Suite 1200 Washington, District of Columbia 20005
OCT 3 0 1997
Re: K973179
Trade Name: Feminique™ Sonic Hair Remover Regulatory Class: III Product Code: KCX Dated: August 22, 1997 Received: August 25, 1997
Dear Ms. Rodriguez:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Samia N. Rodriguez
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): 973179
Feminique Sonic Hair Remover Device Name:
Indications For Use:
For the removal of hair
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H. Oviedo
(Division Sign-Off) (Division of General Restorative Devices Ka73179 510(k) Number.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)