(102 days)
Not Found
No
The device description and performance studies focus solely on LED light therapy technology and usability, with no mention of AI or ML.
Yes
The device is indicated to treat a medical condition (mild to moderate inflammatory acne) using LED light therapy for a direct therapeutic effect.
No
Explanation: The device is indicated for the treatment of acne, not for diagnosis. There is no mention of it being used to identify, detect, or characterize a disease or condition.
No
The device description explicitly states it is a "wand" that emits LED light and has an "On" button, indicating it is a physical hardware device.
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 for diagnosis, monitoring, or screening.
- Device Function: The Acne Light Therapy Wand directly applies light to the skin for treatment. It does not analyze any biological samples.
- Intended Use: The intended use is to treat acne, not to diagnose or analyze a condition based on a sample.
The device description and intended use clearly indicate a therapeutic device that interacts directly with the patient's body, not an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.
Product codes
OLP
Device Description
The Acne Light Therapy Wand uses known LED light therapy technology for the treatment of acne. A combination of blue light and red light is emitted. The Acne Light Therapy Wand device does not emit any ultraviolet (UV) light. UV light is defined as light with the range of 100-400nm. To use the Acne Light Therapy Wand device, users place the device over the treatment area and press the "On" button on the device to start treatment. The device will automatically turn off after each treatment cycle.
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)
The Acne Light Therapy Wand device conforms to the requirements of IEC 60601-1 3rd edition, IEC 60601-1-2, and IEC 62471.
Additionally, a Self Selection and Usability Study was conducted with laypersons and demonstrated that the Acne Light Therapy Wand is an easy to use device and the packaging and labeling are appropriate for and easily understood by the layperson.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is composed of three intertwined lines, representing the three branches of government.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2016
Zuko, Inc. % Ms. M. Joyce Heinrich President Texas Applied Biomedical Services (T.A.B.S.) 12101 Cullen Blvd, Suite A Houston, Texas 77047
Re: K160691 Trade/Device Name: Acne Light Therapy Wand 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: OLP Dated: May 16, 2016 Received: May 19, 2016
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jennifer R. Stevenson -A
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
2
Indications for Use
510(k) Number (if known) K160691
Device Name Acne Light Therapy Wand
Indications for Use (Describe)
The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Texas Applied Biomedical Services (T.A.B.S.) Traditional 510(k) Premarket Submission Model: Acne Light Therapy Wand
510(k) Summary for Acne Light Therapy Wand
1. Submission Sponsor
Zuko, Inc.
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 Email: Tabsii2@comcast.net
3. Date Prepared
17 June 2016
4. Device Name
Trade/Proprietary Name: Acne Light Therapy Wand Common/Usual Name: Acne Light Therapy System Classification Name: Over-the-counter powered light based laser for acne Classification Regulation: 21CFR 878.4810 Classification Panel: General and Plastic Surgery Product Code: OLP Device Class: II FDA Establishment Registration #: To be obtained after clearance
5. Predicate Devices
- Tanda Zap Mini Skincare System 510(k) number K124042, cleared on April 02, 2013, manufactured by Syneron Beauty Inc.
- LightStim for Acne 510(k) number K142246, cleared on January 29, 2015, manufactured by LED Intellectual Properties, LLC
-
- Device Description
4 NOTE: OLP is the best description and closest match to this device. However the device uses LED light sources; there is no coherent (laser) light involved.
4
The Acne Light Therapy Wand uses known LED light therapy technology for the treatment of acne. A combination of blue light and red light is emitted. The Acne Light Therapy Wand device does not emit any ultraviolet (UV) light. UV light is defined as light with the range of 100-400nm. To use the Acne Light Therapy Wand device, users place the device over the treatment area and press the "On" button on the device to start treatment. The device will automatically turn off after each treatment cycle.
7. Intended Use
The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.
8. Technological Characteristics and Substantial Equivalence
This document uses the term "substantial equivalence" as defined in 21 CFR 807.87 and not as defined in Title 35 of the U.S. Code.
The Acne Light Therapy Wand device is substantially equivalent to the Tanda Mini Skincare System and the LightStim for Acne devices in safety and efficacy. All are hand-held, LED light therapy wand devices indicated for the treatment of mild to moderate inflammatory acne.
The properties and characteristics of the subject and predicate devices are compared in the table below.
| Trade Name | Acne Light Therapy
Wand | Tanda Mini
Skincare System | LightStim for Acne |
|--------------------------|----------------------------|-------------------------------|--------------------|
| 510(k) Number | K160691 | K124042 | K142246 |
| Regulation
Number | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 |
| Over-the-counter
use? | Yes | Yes | Yes |
Table 1. Acne Light Therapy Wand vs. Tanda Mini Skincare and LightStim for Acne Systems
5
| Overall design | Portable battery powered device applied to the face providing LED light output. | Portable battery powered device applied to the face providing LED light output. | Mains powered hand-held device applied to the face providing LED light output. |
|---|---|---|---|
| Materials | Polypropylene, Polycarbonate, Aluminum | Polypropylene, Polycarbonate | Polypropylene, Polycarbonate, |
| Wavelength | $442 \pm 4nm$ | ||
| $633 \pm 4nm$ | $415 \pm 4nm$ | $411 \pm 4 nm$ | |
| $640 \pm 4 nm$ | |||
| Treatment Area (cm^2) | 1.594 | 4.155 | 16.6 |
| Dose Rate (mW/cm^2) | |||
| Blue | 26.5 | 36.2 | 12.4 |
| Red | 7.5 | n/a | 6.3 |
| Total | 34.0 | 36.2 | 18.7 |
| Dose (J/cm^2) | |||
| Blue | 9.6 | 13.0 | 8.9 |
| Red | 2.6 | n/a | 4.5 |
| Total | 12.2 | 13.0 | 13.4 |
| Performance Data | Complies with applicable performance specifications and usability requirements. | Complies with applicable performance specifications and usability requirements. | Complies with applicable performance specifications and usability requirements. |
| IEC 60601 Compliant | Yes | Yes | Yes |
| Electrical Power | 1 AAA alkaline batteries | 3 AAA alkaline batteries | AC/DC adapter |
| User Interface | On/off button, | ||
| located on the | |||
| device. Device turns | |||
| on with a push of the | |||
| button and turns off | |||
| automatically. There | |||
| are no other user | |||
| selectable | |||
| parameters. | On/off button, | ||
| located on the | |||
| device. Device turns | |||
| on with a push of the | |||
| button and turns off | |||
| automatically. There | |||
| are no other user | |||
| selectable | |||
| parameters. | On/off button, | ||
| located on the | |||
| device. Device turns | |||
| on/off with a push of | |||
| the button. There | |||
| are no other user | |||
| selectable | |||
| parameters. |
6
Texas Applied Biomedical Services (T.A.B.S.) Traditional 510(k) Premarket Submission Model: Acne Light Therapy Wand
9. Non-Clinical Testing
The Acne Light Therapy Wand device conforms to the requirements of IEC 60601-1 3rd edition, IEC 60601-1-2, and IEC 62471.
Additionally, a Self Selection and Usability Study was conducted with laypersons and demonstrated that the Acne Light Therapy Wand is an easy to use device and the packaging and labeling are appropriate for and easily understood by the layperson.
10. Clinical Testing
The Acne Light Therapy Wand is substantially equivalent to predicate devices currently in commercial distribution in the USA. Therefore, clinical testing of the device was not conducted.
11. Conclusion
By definition, a device is substantially equivalent to a predicate devices 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(s), 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 Acne Light Therapy Wand has the same intended use and technological characteristics as the predicate devices and does not raise any questions regarding its safety and effectiveness. The Acne Light Therapy Wand device, as designed and manufactured, has been found to be substantially equivalent to the predicate devices.