(140 days)
Not Found
Not Found
No
The device description focuses on the hardware components and the use of red light therapy. There is no mention of AI, ML, image processing, or any data-driven algorithms. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended to be used for the treatment of wrinkles, rhytides, and fine lines in the periorbital region, which denotes a therapeutic purpose.
No
The "Intended Use / Indications for Use" states the device is for "treatment of wrinkles, rhytides, and fine lines," not for diagnosis.
No
The device description explicitly lists hardware components such as a control unit, treatment head, recharging stand, AC adapter, and goggles, and describes the physical application of the device to the skin.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of wrinkles, rhytides, and fine lines in the periorbital region." This is a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a light-based system applied directly to the skin for treatment. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of diagnostic markers or assays.
Therefore, the Tända Max OTC System is a therapeutic device, not an in vitro diagnostic device.
N/A
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.
Product codes
GEX, OHS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 Tända Max OTC System has been tested and found in conformance with the requirements of EC 60601, including EMC and EMI. It has also been shown to comply with the requirements of IEC 60825, and ISO 1093 for biocompatibility. Tanda Max OTC was developed under a Quality Management System conforming to ISO 13485;2003 and ISO 14971:2007. A clinical evaluation was successfully performed and the results of which are provided in this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
510(k) SUMMARY
Pharos Life's Tända Max OTC System
AUG - 3 2011
| Contact Information: | Pharos Life Corporation
11-380 Jamieson Pkwy,
Cambridge, ON N3C 4N4
P: (519) 651-1177
F: (519) 651-2277
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.
1
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.
2
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.
3
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
4
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)
14
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