(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 algorithmic processes indicative of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No
The device is intended for hair removal, which is generally considered a cosmetic procedure and not a therapeutic one aimed at treating a disease or medical condition.
No
The device is described as a hair removal tool that destroys hair papillae using radio frequency energy, which is a treatment rather than a diagnostic function.
No
The device description explicitly states it works by emitting radio frequency energy from "tweezer tips," indicating a physical hardware component is essential to its function.
Based on the provided information, 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 testing is done outside the body (in vitro).
- Device Description: The description clearly states the device works by applying radio frequency energy directly to hair grasped by tweezers on the body. This is an in vivo (within the living body) application, not an in vitro test on a specimen.
- Intended Use: The intended use is "For the removal of hair," which is a cosmetic or therapeutic procedure performed on the body, not a diagnostic test on a sample.
Therefore, this device falls outside the scope of In Vitro Diagnostics.
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
Not Found
Key Metrics
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
510 (k) SUMMARY
ni
OCT 30 1997
Sonique™ Hair Remover Trade name:
Global TV Concepts Ltd. Marketed by: 776 South Military Trail Deerfield Beach, Florida 33442 (954) 570-9998; fax (954) 570-9990 Contact: Ms. Laurie Braden
Date prepared: August 22, 1997
Sonic hair remover Common name:
Classification Tweezer-type epilator (per 21 C.F.R. § 878.5360) name :
Intended use: Hair removal
- 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 that the hair does not grow back. More than one treatment may be necessary.
- The device is substantially equivalent to the Substantial IGIÁ Hair Removal System, another tweezer-type equivalence: epilator. Both devices emit a 27 MHz radio frequency signal, with a peak reading of dBuV 107.15 for the Sonique™ and dBuV 105.6 for the IGIA. The principal difference between the products is that the Sonique™ Hair Remover relies on 4 "AAA" batteries for its operation, whereas the IGIA Hair Removal System uses household electrical enerqy. Also the Sonique™ uses 6V of electricity to generate the radio frequency signal, whereas the IGIA 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
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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: K973174
Trade Name: Sonique™ 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 Quality 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,
Asevedo
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
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510(k) Number (if known): K973174
Device Name: Sonique Hair Remover
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)
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(Division Sign-Off) Division of General Restorative Devices 6973174 510(k) Number J
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)