(214 days)
No
The summary mentions "onboard electronic controls and intelligence" but does not explicitly state or provide evidence of AI or ML being used for decision-making, image processing, or any other function typically associated with these technologies in medical devices. The focus is on phototherapeutic light treatment.
Yes
The device is described as administering "phototherapeutic light to the body in order to treat Acne" and generally indicated to "treat dermatological conditions," specifically "mild to moderate inflammatory acne," which implies a therapeutic purpose.
No
The device is described as administering phototherapeutic light to treat acne and other dermatological conditions. It does not mention diagnosing any conditions, only treating them.
No
The device description explicitly states it is a "modular platform which uses light treatment heads combined with onboard electronic controls and intelligence," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer phototherapeutic light to the body to treat acne and other dermatological conditions. This is a direct treatment applied to the patient's body.
- Device Description: The device uses light treatment heads and electronic controls to deliver light therapy. This is an external therapeutic device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a therapeutic device that applies light directly to the body.
N/A
Intended Use / Indications for Use
The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne.
The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
Product codes
GEX
Device Description
The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Ko70185
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted by: Pharos Life Corporation 11-380 Jamieson Parkway Cambridge, Ontario N3C 4N4
1. Date Prepared:
July 30, 2007
2. Contact Person:
Phil Cuscuna Tel.: 519 651-1177, ext 225 Fax: 519 651-2277 Email: phil.cuscuna@pharoslife.com
3. Device Name and Classification:
| Trade Name: | Tända Skincare System |
|---|---|
| Common Name: | Tända Skincare System |
| Classification Name: | Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| Classification Panel: | General & Plastic Surgery |
| CFR Section: | 21 CFR §878.4810 |
| Device Class: | Class II |
| Device Code: | GEX |
4. Intended Use:
The Tända Skincare System is a device intended to administer phototherapeutic light to the body in order to treat Acne.
5. Substantial Equivalence:
The Tända Skincare System is substantially similar to:
BLU-U, MODEL 4170, DUSA PHARMACEUTICALS, INC K031805 (Sep 9, 2003)
1
K0701PT
Device Description: 6.
The Tända Skincare System is a modular platform which uses light treatment heads combined with onboard electronic controls and intelligence designed to offer solid state light source treatments for mild to moderate inflammatory acne.
7. Comparison of Technological Differences:
The intended use and technological characteristics of the Tända Skincare System are virtually identical to the intended use and technological characteristics of the listed equivalent device. Any differences between the Tända Skincare System and the equivalent device have no significant influence on safety or effectiveness of the Tända product.
8. Additional Safety Data:
The Tända Skincare System has undergone certification to IEC 60601-1. In addition, testing and analysis have demonstrated compliance to: ISO 10993 (Biocompatibility) and IEC 60825-1 (Laser Safety). The later demonstrated an Accessible Emission Limit (AEL) below the AEL Class I threshold.
The ocular hazard level presented by unprotected exposure to the Tända Skincare light source was determine by applying the calculations specified in Threshold Limit Values for Chemical Substances and Physical Agents & Biological Exposure Indices of the American Conference of Governmental Industrial Hygienists Worldwide and the standards of the International Commission on Non-ionizing Radiation Protection. The results indicated that the Tända Skincare System - did not pose a risk of retinal injury due to either the blue-light phototoxic effect, or the thermal damage mechanism. In addition, there were no additive effects from light exposure.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with three lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pharos Life Corporation % Mr. Phil Cuscuna Quality & Regulatory Affairs Manager 11-380 Jamieson Parkway Cambridge, Ontario Canada, N3C 4N4
AUG 2 1 2007
Re: K070185
Trade/Device Name: Tända Skincare System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 30, 2007 Received: July 31, 2007
Dear Mr. Cuscuna:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
3
Page 2 - Mr. Phil Cuscuna
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
thichard D. Cappe
FOR
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: K070185
Device Name: Tända Skincare System
Indications For Use:
The tända Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
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)
thutary P. Cooper
(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Overological Devices
510(k) Number K070185