PRO X OTC 5
Device Facts
| Record ID | K140471 |
|---|---|
| Device Name | PRO X OTC 5 |
| Applicant | La Lumiere, LLC |
| Product Code | OHS · General, Plastic Surgery |
| Decision Date | Jan 15, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Pro X OTC 5 is an Over-The-Counter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I, II and/or III.
Device Story
Pro X OTC 5 is an over-the-counter light therapy mask for facial wrinkle reduction. Device uses LED technology to emit red (620-630nm) and infrared (855nm) light. User places mask over face and activates via controller; device automatically shuts off after 900-second treatment cycle. Designed for 30 sessions per device; full 60-session regimen requires two devices. Intended for home use by laypersons. Output is non-invasive light therapy; clinical benefit is reduction in facial wrinkle severity as measured by Fitzpatrick Wrinkle and Elastosis Scale. Healthcare providers do not operate the device; efficacy is assessed by clinicians via standardized photography.
Clinical Evidence
8-week prospective clinical study with 50 subjects (30 treatment, 20 control). Primary endpoint: change in Fitzpatrick Wrinkle and Elastosis Scale scores evaluated by two blinded physicians. Treatment group showed statistically significant improvement at 8 weeks and 20 weeks post-treatment compared to baseline (p<0.001 vs control). Mean improvement of ~1.2 points on 9-point scale. Control group showed no statistically significant improvement.
Technological Characteristics
LED-based light therapy system. Wavelengths: 620-630 nm (red), 855 nm (infrared). Power density: 0.016 mW/cm^2 (red), 0.0029 mW/cm^2 (infrared). Form factor: wearable mask with external controller. Conforms to IEC 60601-1 (3rd ed), IEC 60601-1-2, and IEC 62471. Standalone operation; battery/power-driven.
Indications for Use
Indicated for treatment of facial wrinkles in adults with Fitzpatrick skin types I, II, and III.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
La Lumiere, LLC % M. Joyce Heinrich Texas Applied Biomedical Services 12101 Cullen Boulevard, Suite A Houston, Texas 77047
Re: K140471
Trade/Device Name: Pro X OTC 5 Light Therapy Device 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: OHS Dated: December 29, 2014 Received: December 31, 2014
Dear Ms. Heinrich:
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.
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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# David Krause -S
- for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K140471
Device Name Pro X OTC 5 Light Therapy Device
Indications for Use (Describe)
The Pro X OTC 5 is an Over-The-Counter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I, II and/or III.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 510(k) Summary for Pro X OTC 5 Light Therapy Device
#### 1. Submission Sponsor
La Lumiere, LLC
#### 2. Submission Correspondent
Texas Applied Biomedical Services (T.A.B.S.) 12101 Cullen Blvd, Suite A Houston, Texas 77047 Phone: (713) 734-4433 Fax: 1-866-362-3968 Contact: M. Joyce Heinrich, President
## 3. Date Prepared
15 January 2015
#### 4. Device Name
Trade/Proprietary Name: Pro X OTC 5 Common/Usual Name: Wrinkle Light Therapy System Classification Name: Light Based Over- the-Counter Wrinkle Reduction Classification Regulation: 21CFR 878.4810 Classification Panel: General and Plastic Surgery Product Code: OHS Device Class: II FDA Establishment Registration #: To be obtained after clearance
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## 5. Predicate Devices
Lightstim for Wrinkles (K120775) manufactured by LED Intellectual Properties, LLC; illuMask Acne Mask (K123999) manufactured by La Lumiere, LLC.
# 6. Device Description
The Pro X OTC 5 is an Over-the-Counter device intended for use in the treatment of facial wrinkles. Facial wrinkles are lines on the skin that appear as you age. Facial wrinkles can appear anywhere on the face, such as on the forehead, around the eyes, and by the mouth. The Pro X OTC 5 is for people with wrinkles on their face and who have Fitzpatrick skin types I, II, and/or III.
The Pro X OTC 5 uses known LED light therapy technology. A combination of red light (620-630mm) and infrared light (855nm) is emitted. To use the Pro X OTC 5 device, users place the lightweight mask over the face and then press the "On" button on the controller to start treatment. The device will automatically turn off after each treatment cycle.
The Pro X OTC 5 device is designed to be used for 30 treatment sessions. The full treatment regimen for facial wrinkles includes 60 individual treatments, therefore purchase of two (2) devices is needed to receive the full treatment regimen.
| Parameter | Specification |
|------------------------------------------------|---------------|
| Wavelengths of: | |
| Red light | 620-630 nm |
| Infrared light | 855 nm |
| Power Density (mW/cm^2): | |
| Red light | .016 |
| Infrared light | .0029 |
| Total Dose Energy (J/cm2) / 60<br>Treatments: | |
| Red light | 0.86 |
| Infrared light | 0.16 |
| Overall Total Energy (J) / 60<br>Treatments | 332 |
| Individual Treatment Time (seconds) | 900 |
| Total Treatments per Full Treatment<br>Regimen | 60 |
| Treatment cycles per device | 30 |
## Technical Specifications
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#### 510(k) Premarket Submission K140471
### 7. Intended Use
The Pro X OTC 5 is an Over-The-Counter device intended for use in the treatment of facial wrinkles. It is for people with wrinkles on their face and who have Fitzpatrick skin types I, II and/or III.
# 8. Non-Clinical Testing
The Pro X OTC 5 device conforms to the requirements of IEC 60601-1 3rd edition, IEC 60601-1-2. and IEC 62471.
Additionally, the Pro X OTC 5 Device was evaluated by the typical layperson in two separate studies: 1) Usability Study and 2) Self-Selection Study. The Usability Study was developed and conducted with 20 participants randomly selected from the general public representative of the population to which the Pro X OTC 5 Device is intended to be marketed to. This study evaluated the labeling aspects of the device to determine the understanding of the naïve layperson that are representative of the adult population for which the device is marketed.
The overall results of the Usability Study demonstrated that the participants in this study successfully completed the evaluation of the three major aspects of the study design: 1) outer packing and box label, 2) Instructions for Use (manual included inside the packaging), and 3) use of the device by laypersons.
The objective of the Self-Selection study was to evaluate the external packaging (box labeling) of the Pro X OTC 5 device by the naïve layperson to determine if there is sufficient information visible for them to decide (self-select) whether or not to use the device. A total of 20 participants, ranging in from 18 years and older, were randomly asked to review the external package labeling of the Pro X OTC 5 and complete a questionnaire at the end of their review. The results of this study demonstrated that the external packaging is in a language that is fully understood by a randomly selected group of naïve laypersons that are representative of the adult population for which the device is marketed.
# 9. Clinical Testing
An 8-week clinical study was conducted with 50 subjects with Fitzpatrick Skin tvpes I - III. 30 of which were randomly assigned into the Treatment Group and used the Pro X OTC 5, and 20 of which were randomly assigned into the Control Group and used a placebo mask. All subjects underwent an eight (8) week treatment regime followed by a 3-month post treatment (20-weeks) evaluation. The subjects used the device for 60 times during the 8 weeks period.
Standardized facial photographs were made at baseline and each subsequent evaluation period. The device was used by the subjects for 8 weeks and the last assessment photos were taken 3 months after the last treatment. The photographs were evaluated by two independent, blinded, licensed physicians using the 9-point Fitzpatrick Wrinkle and Elastosis Scale. The statistical analysis of the outcome measure of wrinkles demonstrated that the Pro X OTC 5 Device is effective in the treatment of facial wrinkles.
The Treatment Group demonstrated absolute improvement in the Fitzpatrick scores for both physicians at all evaluation periods. For Physician 1 the mean baseline grade was 5.10, and after 8-weeks the
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grade was 3.86, a difference of 1.24 points. At the 20-weeks post treatment evaluation, further reduction was realized with a grade of 3.83, a difference of 1.28-points from baseline. For Physician 2 the mean baseline grade was 5.03. and after 8-weeks the grade was 3.83. a difference of 1.21 points. At the 20-weeks post treatment evaluation, further reduction was realized with a grade of 3.90, a difference of 1.14-points from baseline. Each subject demonstrated at least 1 point improvement individually based on the comparison between baseline and 20-weeks post treatment follow up pictures.
The Treatment Group showed statistically significant improvement in Fitzpatrick score at all evaluation periods, whereas, the Control Group did not show statistically significant improvement in the Fitzpatrick Score at any evaluation period.
The Treatment Group statistically outperformed the Control Group at all evaluation periods: 8-weeks and 20-weeks evaluation for both physicians, p<0.001.
# 10. Conclusion
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device may have the same intended use and different technological characteristics if they can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regards its safety and effectiveness as compared to the predicate device.
We have shown in this 510(k) submission that the Pro X OTC 5 has the same intended use and technological characteristics as the predicate devices and does not raise any questions regarding its safety and effectiveness. The Pro X OTC 5 device, as designed and manufactured, has been found to be substantially equivalent to the predicate devices.
