The Tända Max OTC System is a modular system that offers simplicity in use and convenience. The system can operate while connected directly to an electrical outlet or can be used in cordless mode drawing upon its rechargeable batteries to deliver the treatment. The system components include the control unit, the treatment head, recharging stand, AC adapter, and goggles. The Tända Max OTC System utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.

AI/ML Overview

Based on the provided text, the Tända Max OTC System is a light therapy device intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for de novo device approval.

Therefore, the information available is limited regarding specific acceptance criteria and the detailed methodology of the clinical study. However, I can extract the available information and highlight what is not present.

Here's the breakdown of the information requested, based on the provided text:

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

The provided document does not explicitly state specific quantitative acceptance criteria for clinical efficacy (e.g., "X% reduction in wrinkle depth"). Instead, it broadly states that "A clinical evaluation was successfully performed and the results of which are provided in this application." This implies that the clinical evaluation demonstrated a positive outcome consistent with the intended use, but the specific metrics and targets are not detailed in this summary.

Acceptance Criteria	Reported Device Performance
Not explicitly defined in the provided text for clinical efficacy measures. The document states "A clinical evaluation was successfully performed and the results of which are provided in this application," implying the device successfully demonstrated its intended effects.	The Tända Max OTC System is as safe and effective as the prescriptive Tända Max System and the Light for Wrinkles (predicate devices), with similar indications, technological characteristics, and principles of operation. Performance data demonstrate substantial equivalence.

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

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text only mentions "A clinical evaluation was successfully performed."

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)

This information is not provided in the text. Given the nature of wrinkle treatment, ground truth for efficacy would typically be established by dermatologists or plastic surgeons, but the number and qualifications are not mentioned.

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

This information is not provided in the text.

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

No MRMC comparative effectiveness study was mentioned or implied. This device is a light therapy device, not an AI-assisted diagnostic or interpretive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.

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

This question is not applicable as the Tända Max OTC System is a physical light therapy device, not a software algorithm. Its performance is inherent in its direct application and physiological effect, not in an interpretive algorithm.

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

The specific type of ground truth used to assess the efficacy of wrinkle reduction is not explicitly stated. For wrinkle treatment, this typically involves photographic analysis, grading scales (e.g., Fitzpatrick Wrinkle Scale, photonumeric scales), and possibly patient self-assessment, often evaluated by expert clinicians (dermatologists/plastic surgeons). The summary only states "A clinical evaluation was successfully performed."

8. The sample size for the training set

This information is not provided in the text.
Note: For a medical device like this, the term "training set" is usually not applicable in the same way it is for machine learning algorithms. If there was any "training" data, it would refer to data used during early R&D or pilot studies, which are distinct from the formal clinical evaluation.

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

This information is not provided and is largely not applicable in the context of this device as explained in point 8.

Summary

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K110735

510(k) SUMMARY

Pharos Life's Tända Max OTC System

AUG - 3 2011

Contact Information:	Pharos Life Corporation11-380 Jamieson Pkwy,Cambridge, ON N3C 4N4P: (519) 651-1177F: (519) 651-2277Contact Person: Gordon Wehner
Date Prepared:	March 15, 2011

Tända Max OTC System Device Name:

Common or Usual Name: Light Therapy Device

Classification Name:

Laser Instrument, Surgical, Powered (Laser surgical instrument for use in general and plastic surgery and dermatology) Regulation No. 878.481 0 Product Code: GEX

Predicate Devices:	Manufacturer	Device
	Pharos Life	Tända Max System
	LED Intellectual Properties	Anti-wrinkle Light

Intended Use / Indications for Use:

The Tända Max OTC System is intended to be used for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.

Technological Characteristics

The Tända Max OTC System utilizes red light at 660 nm. The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The surface that comes into contact with the skin has been selected to ensure the light is administered to the skin while providing a smooth surface for cleaning.

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Performance Data

The Tända Max OTC System has been tested and found in conformance with the The Tända Max OTC System has been tested and louits in combination for comply with
requirements of EC 60601, including EMC and EMI. It has also been shown to comply with requirements of IEC 60601, including EMC and EMI. Tims also boor enterest.
the requirements of IEC 60825, and ISO 1093 for biocompatibility. Tanda Max OTC was
SO the requirements of IEC 60825, and SO 1099 to fibroinpulsuring to ISO 13485;2003 and ISO
developed under a Quality Management System conforming to ISO 13485;2003 and ISO developed under a Quality Management System conforming to 100 1002011
14971:2007. A clinical evaluation was successfully performed and the results of which are provided in this application.

Substantial Equivalence

The Tända Max OTC System is as safe and effective as the prescriptive Tända Max System
The Tända Max OTC System The Tijude Max OTC System has the same intended uses and The Tända Max OTC System is as sate and enective as the processor intended uses and
and the Light for Wrinkles. The Tanda Max OTC System has its predicate and the Light for Wrinkles . The Tânda Max CTC System rias in operation as its predicate
similar indications, technological characteristics, and principles of operation and similar indications, technological characteristics, and philopics on operation and its
device. The minor technological differences between the Tända Max OTC System and its device. The minor technological differences between interness. Performance data
predicate devices raise no new issues of safety or effectiveness. Performance data predicate devices raise no new issues of salely of eneburned. Portugues its predicates.
demonstrate that the Tända Max OTC System is as safe and effective as its predicates. demonstrate that the Tanda Max OTC System is substantially equivalent.
Thus, the Tända Max OTC System is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Pharos Life Corporation % Hogan and Hartson Mr. Johnathan S. Kahan 555 Thirteenth Street, NW Washington, District of Columbia 20004

AUG - 3 2011

Re: K110735

Trade/Device Name: Tanda Max OTC System 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: June 28, 2011 Received: June 28, 2011

Dear Mr. Kahan;

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.

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Page 2 - Mr. Johnathan S. Kahan

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Mark N Millkum

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K110735 510(k) Number (if known):

Device Name: Tända Max OTC

Indications for Use:

Tända Max OTC is intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

oncurrence of CDRH, Office of Device Evaluation (ODE)

NukRe Ql for an

(Division Sign Off)

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110735

Page 1 of 1

\\DC - 032690/000001 - 3215945 v2

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.