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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Acne Light Therapy Wand." It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria in terms of clinical performance.

Based on the document, here's an analysis of what is and isn't available for your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of clinical acceptance criteria for the device's performance in treating acne, nor does it report clinical performance data against such criteria. The "Performance Data" in Table 1 (page 5) simply states: "Complies with applicable performance specifications and usability requirements." This refers to non-clinical performance (e.g., electrical safety, usability), not clinical efficacy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No clinical testing was conducted for the Acne Light Therapy Wand (page 6, Section 10). Therefore, there is no clinical test set for which to determine sample size or data provenance.

A "Self Selection and Usability Study" was conducted (page 6, Section 9) with laypersons, but details on the sample size for this study are not provided. This was a non-clinical study focused on usability and understanding of instructions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical testing was performed to establish ground truth for clinical efficacy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical testing was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an acne light therapy wand, not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for clinical efficacy. For the usability study, the "ground truth" would be the ease of use and understanding by laypersons, assessed through direct interaction and feedback, but the method for establishing this "ground truth" is not detailed beyond stating it "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."

8. The sample size for the training set

Not applicable, as no algorithm or machine learning model is involved, and no clinical training set was used.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary of what the document does provide:

The 510(k) submission argues for substantial equivalence based on:

Intended Use: The same as predicate devices (treatment of mild to moderate inflammatory acne) (page 4, Section 7).
Technological Characteristics: Comparison of physical design, materials, wavelengths, dose rates, and electrical power with predicate devices (Table 1, pages 5-6).
Non-Clinical Testing:
- Conformity to international standards for electrical safety (IEC 60601-1 3rd edition, IEC 60601-1-2) and photobiological safety (IEC 62471).
- A "Self Selection and Usability Study" with laypersons, demonstrating ease of use and understandable labeling (page 6, Section 9).

The core of this submission is the argument that because the device is substantially equivalent to legally marketed predicate devices, clinical testing (and thus, specific acceptance criteria for clinical performance) was not required for clearance. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing and the comparison to predicate devices, asserting that these are sufficient to demonstrate safety and effectiveness without new clinical data.

Summary

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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

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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

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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)

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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
1. 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.

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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 TherapyWand	Tanda MiniSkincare System	LightStim for Acne
510(k) Number	K160691	K124042	K142246
RegulationNumber	21CFR 878.4810	21CFR 878.4810	21CFR 878.4810
Over-the-counteruse?	Yes	Yes	Yes

Table 1. Acne Light Therapy Wand vs. Tanda Mini Skincare and LightStim for Acne Systems

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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 thedevice. Device turnson with a push of thebutton and turns offautomatically. Thereare no other userselectableparameters.	On/off button,located on thedevice. Device turnson with a push of thebutton and turns offautomatically. Thereare no other userselectableparameters.	On/off button,located on thedevice. Device turnson/off with a push ofthe button. Thereare no other userselectableparameters.

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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.

Regulation Number and Section

§ 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.