(96 days)
The FINALLY FREE Ultra tweezer-type epilator is indicated for the removal of unwanted body and facial hair. Like the predicated in the is specifically dosigned for use h is specifically designed for use by consumers.
Finally Free Ultra is a tweezer-type epilator for the removal of unwanted body and facial hair. It is designed for consumer home use. The device removes hair by the application of radio frequency energy to the hair shaft, which in turn conducts it to the hair root. There the energy causes the root to separate from follicle, thereby causing the hair to fall out. Further damage to the surrounding tissue stunts hair growth. This patented process is called NU-Trolysis. Finally Free Ultra is substantially equivalent to Forever Free, another consumer-use tweezer-type epilator manufactured by Burke/Neutech (K952117). Both are plastic encased units which plug into a standard 110V wall socket and which convert the AC current into radio frequency energy by means of a crystal oscillating component and both amplifying and filtering circuitry. The energy is delivered by a line cord attached to a hand-held wand with a tweezer which grasps the individual hair.
Here's an analysis of the provided text regarding the "FINALLY FREE ULTRA" epilator, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
The document provided does not specify explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy, as would be typical for diagnostic or AI-driven devices. Instead, the "acceptance" in this context is based on demonstrating substantial equivalence to a predicate device for regulatory clearance.
The core performance comparison is regarding the energy outputs of the device compared to its predicate:
| Characteristic | Acceptance Criteria (Predicate: FOREVER FREE) | Reported Device Performance (FINALLY FREE ULTRA) |
|---|---|---|
| Frequency (MHz) | 27.064 - 27.112 | 27.100 - 27.322 |
| Voltage (p-p) | 30.1 - 31.2 | 39.2 - 59.4 |
Note on "Acceptance Criteria": For this type of device and regulatory submission (510(k)), "acceptance criteria" for performance are not typically quantitative thresholds like those used for AI. Instead, the criteria are centered around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data presented (frequency and voltage ranges) are used to support the claim of substantial equivalence, implying that these ranges are within what is deemed acceptable for similar devices. The wider range for "Finally Free Ultra" in both frequency and voltage suggests it either operates across a broader spectrum or potentially with higher power, but the document implies this is still considered "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions that the energy outputs for "FINALLY FREE ULTRA" were measured using "6 Units" and for "FOREVER FREE" using "2 Units." This small sample size of devices (not patients or data points) was used for the direct electrical performance comparison.
- Data Provenance: Not explicitly stated as retrospective or prospective data from a human study. This is an engineering/device performance measurement, likely performed in a lab setting by the manufacturer (Burke/Neutech). The country of origin of this data is not specified beyond being generated by the applicant.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for the electrical performance metrics (frequency and voltage) is the direct measurement of outputs from the devices themselves using instrumentation. There are no human experts involved in establishing this type of ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is an objective electrical measurement, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an epilator, not an AI or diagnostic device that would typically involve human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this question is not applicable to the device described. This device is a physical epilator, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the "performance data" (frequency and voltage) is direct instrumental measurement of the device's electrical output. For the broader claim of "substantial equivalence" regarding hair removal, the implied "ground truth" would be the established safety and effectiveness of the predicate device, "Forever Free," for its intended use.
8. The Sample Size for the Training Set
Not applicable. This is a physical device submission demonstrating substantial equivalence, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an algorithm.
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Image /page/0/Picture/0 description: The image shows the date October 22, 1997. The month is abbreviated to OCT. The numbers are written in a simple, sans-serif font. The text is black on a white background.
Image /page/0/Picture/1 description: The image shows a logo with a black circle on the left side. The circle has some white dots inside. To the right of the circle, the text "EHL / Group Marketing Consumer Products Division" is displayed in a stylized font.
510(k) SUMMARY
FINALLY FREE ULTRA
Finally Free Ultra is a tweezer-type epilator for the removal of unwanted body and facial hair. It is designed for consumer home use. Reviewed by the General and Plastic Surgery Device Classification Panel, tweezer-type epilators are assigned the Product Code KCX and are regulated under 21 CFR 878.5360. Tweezer-type epilators are Class III devices, although FDA has proposed reclassifying them into Class I.
The device removes hair by the application of radio frequency energy to the hair shaft, which in turn conducts it to the hair root. There the energy causes the root to separate from follicle, thereby causing the hair to fall out. Further damage to the surrounding tissue stunts hair growth. This patented process is called NU-Trolysis.
Finally Free Ultra is substantially equivalent to Forever Free, another consumer-use tweezertype epilator manufactured by Burke/Neutech (K952117). Both are plastic encased units which plug into a standard 110V wall socket and which convert the AC current into radio frequency energy by means of a crystal oscillating component and both amplifying and filtering circuitry. The energy is delivered by a line cord attached to a hand-held wand with a tweezer which grasps the individual hair.
Energy outputs for the two devices were measured as follows:
| FINALLY FREE(6 Units) | FOREVER FREE(2 Units) | |
|---|---|---|
| Frequency (MHZ) | 27.100 - 27.322 | 27.064 - 27.112 |
| Voltage (p-p) | 39.2 - 59.4 | 30.1 - 31.2 |
The two devices differ slightly in that much of Finally Free's essential electronic components are contained within the base unit whereas for Forever Free most components are found within the wand. Also, a power select knob is provided with Finally Free, but not for Forever Free.
Thomas Blake, R.Ph. 7/16/97
Date
221 Boston Post Road East · Marlboro, MA 01752 · 508-481-9495 · Fax: 508-460-9541
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Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle head with three stripes extending from the back of the head, representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Thomas Blake, R. Ph. MEHL/Group Marketing 48 Mt. Olive Road Budd Lake, New Jersey 07828
OCT 22 1997
Re: K972695 Trade Name: Finally Free ULTRA Regulatory Class: III Product Code: KCX Dated: July 17, 1997 Received: July 18, 1997
Dear Dr. Blake:
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 (OS) 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 - Thomas Blake, R. Ph.
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,
Mark n Miller
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) _ K972695
Device Name: EINALLY FREE ULTRA_______________________________________________________________________________________________________________________________________________
Indications for Use:
The FINALLY FREE Ultra tweezer-type epilator is indicated for the removal of unwanted body and facial hair. Like the predicated in the
is specifically dosigned for use h is specifically designed for use by consumers.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K972695 |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
OR
| Over-The-Counter Use (Optional Format 1-2-96) | X |
|---|---|
| ----------------------------------------------- | --- |
§ 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.