TANDA MAX

K103415 · Pharos Life Corporation · ONE · Jan 3, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K103415
• Device Name: TANDA MAX
• Applicant: Pharos Life Corporation
• Product Code: ONE · General, Plastic Surgery
• Decision Date: Jan 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Tanda Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.

Device Story

Tända Max is a modular LED light system for periorbital wrinkle treatment. Device components include a control unit, treatment head, recharging stand, pre-treatment gel, AC adapter, and goggles. Operates via direct electrical connection or rechargeable battery. Emits red light at 660 nm; applied directly to skin surface. Treatment regimen consists of 160-second sessions, twice weekly for six weeks. Output intensity is 50 mW/cm2. Designed for consistent light administration; contact surface is smooth for cleaning. Intended for use in reducing fine lines and rhytides.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC/EMI (IEC 60601-1-2), laser safety (IEC 60825), and biocompatibility (ISO 10993).

Technological Characteristics

Modular LED light system; 660 nm wavelength; 50 mW/cm2 output. Powered by AC adapter or rechargeable battery. Biocompatible contact surface. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825, ISO 10993.

Indications for Use

Indicated for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.

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.

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

Submitted by: Pharos Life Corporation 11-380 Jamieson Parkway Cambridge, Ontario N3C 4N4

JAN - 3 2011

The assigned 510(k) number is: K103415

- 1. Date Prepared: Dec 8 2010
- 2. Contact Person: Gordon Wehner Tel: [phone] Fax: [phone]

# 3. Device Name and Classification:

| Device Name | Tanda Max |
|-----------------------|----------------------------------------------------------------------------------------|
| Classification Name | Laser Surgical Instrument for use in general and<br>plastic surgery and in dermatology |
| Common Name | LED Light System |
| Device Classification | 2 |
| Review Panel | General and Plastic Surgery |
| Product Code | GEX |
| Regulation Number | 878.4810 |

# 4. Predicate Devices:

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|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A RELIE MALE IN CHARRENE<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | AMAR RANCE LEBELLER<br>A . A SENS ANDREW AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND | -------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | .<br>A LINE MILLE LE LEGION LE LEAR LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE LE |

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K163415

# 5. Device Description

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Tända Max 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, Pre-treatment gel, AC adapter and goggles.

Tanda Max 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.

# 6. Intended Use:

The Tanda Max System is intended for the treatment of wrinkles, rhytides and fine lines in the periorbital region.

# 7. Comparison of Technological Differences

The technological characteristics of Tanda Max are equivalent to the listed predicate devices. Specifically, Tanda Max:

- 1. Has the same intended use as the predicate (i.e., Treatment of wrinkles, rhytides and fine lines;
- 2. Has the same output (i.e., 50 mW/cm2) as the predicate;
- 3. Utilizes the same wavelength (i.e., 660 nm) as the predicate device;
- 4. Utilizes the same treatment duration (i.e., 160 seconds) as the predicate device;
- 5. Utilizes the same treatment regimen (i.e., two treatments per week for six weeks) as the predicate device.

Any differences between the Tanda Max System and the predicate device are not significant to its safety or effectiveness for its intended use.

#### 8. Summary of non-clinical testing

Tanda Max meets the requirements of IEC 60601-1(electrical safety), IEC 60601-1-2 (EMC and EMI), IEC 60825 (Laser Safety), and ISO 10993 (biocompatibility).

# 9. Clinical Information

Based on the above information, additional clinical information is not necessary.

# 10. Conclusion

Tanda Max meets the safety and efficacy requirements necessary for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G609 Silver Spring. MI) 20993-0002

Pharos Life Corporation % Regulatory Technology Services, LLC Mr. Mark Job 1394 25" Street, NW Buffalo, Minnesota 55313

JAN - 3 - 11

Re: K103415

Trade/Device Name: Tända Max 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: ONE Dated: December 21, 2010 Received: December 22, 2010

Dear Mr. Job:

:

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. Mark Job

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/CDRHQffices/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 vours.

AZ. B. 2

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

510(k) Number: K | O 3 Y | را

Device Name: Tända Max System

Indications For Use:

JAN - 3 2011.

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Ryden for mkn

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

510(k) Number K103415