TANDA MAX OTC SYSTEM

K110735 · Pharos Life Corporation · OHS · Aug 3, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K110735
• Device Name: TANDA MAX OTC SYSTEM
• Applicant: Pharos Life Corporation
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Aug 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Tända Max OTC System is a light therapy device for home use. It utilizes red light at 660 nm to treat periorbital wrinkles, rhytides, and fine lines. The device is a modular system consisting of a control unit, treatment head, recharging stand, AC adapter, and goggles. It operates via rechargeable batteries or direct electrical connection. The user applies the treatment head directly to the skin surface. The light administration is intended to improve skin appearance. The device is designed for consumer self-use.

Clinical Evidence

A clinical evaluation was performed to support the safety and effectiveness of the device. The device also conforms to IEC 60601 (EMC/EMI), IEC 60825, and ISO 10993 (biocompatibility) standards.

Technological Characteristics

Modular light therapy system; 660 nm red light source; rechargeable battery or AC power; includes control unit, treatment head, recharging stand, AC adapter, and goggles. Developed under ISO 13485:2003 and ISO 14971:2007 quality management systems. Complies with IEC 60601, IEC 60825, and ISO 10993.

Indications for Use

Indicated for the treatment of wrinkles, rhytides, and fine lines in the periorbital region for over-the-counter use.

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

• Tända Max System (K110735)
• Anti-wrinkle Light (LED Intellectual Properties)

Submission Summary (Full Text)

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K110735

#### 510(k) SUMMARY

Pharos Life's Tända Max OTC System

AUG - 3 2011

| Contact Information: | Pharos Life Corporation<br>11-380 Jamieson Pkwy,<br>Cambridge, ON N3C 4N4<br>P: [phone]<br>F: [phone]<br>Contact 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 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.

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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 [phone] or [phone] 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)

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NukRe Ql for an

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(Division Sign Off)

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

510(k) Number K110735

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