(61 days)
Not Found
No
The device description explicitly states that the device "does not use any software" and there are no mentions of AI, ML, or related concepts in the summary.
Yes
The device is intended for the "treatment of superficial, benign vascular and pigmented lesions," indicating a therapeutic purpose.
No
The Evis MD Platinum Red Light Therapy device is described as providing light to the body for the treatment of superficial, benign vascular and pigmented lesions. It is a therapy device, not one that identifies or analyzes conditions.
No
The device description explicitly states "Evis MD Platinum Red does not use any software" and describes a hardware device utilizing LEDs.
Based on the provided information, the Evis MD Platinum Red Light Therapy device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Evis MD Platinum Red Function: The description clearly states that the device "provides light to the body" and "delivers the light to the skin as it moves over the skin." This is a direct interaction with the body, not the analysis of a specimen taken from the body.
- Intended Use: The intended use is for treating superficial skin lesions, which is a therapeutic application, not a diagnostic one based on analyzing bodily fluids or tissues.
Therefore, the Evis MD Platinum Red Light Therapy device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Evis MD Platinum Red Light Therapy is intended to provide light to the body.
Generally indicated for dermatology use for the treatment of superficial, benign vascular and pigmented lesions "such as but not limited to solar lentigines, sun spots, liver spots and agent spots".
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Evis MD Platinum Red Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand held device contains the power supplies and a built in audible indicator with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for red is 630 +/- 5 nanometer. Evis MD Platinum Red does not use any software.
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)
The Evis MD Platinum Red was tested and complics with Electrical Safety and EMC testing, which include the requirements of IEC/EN/UL 60601-1 "Medical Electrical Equipment Part 1 - General Requirements for Safety" and was tested in accordance to Medical Directive 93/42/EEC - CSA 601.1, EMC Directive 2004/108/EC IEC/EN 60601-1-2 *Medical Electrical Equipment Part 1-2, General Requirements for Safety - Collateral Standard Electromagnetic Compatibility Requirements and Tests. I'CC 47CRF PT 18 Industrial, Scientific, and Medical Equipment. ICES 005 Radio Frequency Light Device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FDA 510K Summary of Safety and Effectiveness for EVIS MD PLATINUM RED LIGHT THERAPY
1. General Information
| Submitter: | Ageless Beauty Corporation
28470 Avenue Stanford
Suite 350
Valencia, CA 91355
Office: +1 877 629-4429
Fax: +1 661 295-5088 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | C/O Jill Creasy
Aesthetica-Tech
675 Pine Street
Elgin, IL 60123
847-429-9631
contact@aestheticatech.com |
| Summary Preparation Date: | August 6, 2008 |
- Device Name
| Device Name: | Evis MD Platinum Red Light Therapy |
|---|---|
| Classification Name: | Laser Surgical instrument for use in General, Plastic Surgery |
| and in Dermatology | |
| Although this device is not a laser, the specifications | |
| developer feels this is the closest applicable classification | |
| name. | |
| Regulation Number | 21 CFR 878.4810 |
| Regulatory Class | II |
| Product Code | GEX |
3. Predicate Device
The Evis MD Platinum Light Therapy device is substantially equivalent to the Omnilux Revive (K030426),
4. Device Description
The Evis MD Platinum Red Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand held device contains the power supplies and a built in audible indicator with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for red is 630 +/- 5 nanometer. Evis MD Platinum Red does not use any software.
5. Intended Use and Indications:
The Evis MD Platinum Red Light Therapy is intended to provide light to the body.
Generally indicated for dermatology use for the treatment of superficial, benign vascular and pigmented lesions "such as but not limited to solar lentigines, sun spots, liver spots and agent spots".
1
Comparison of Technological Differences: 6.
The intended use and technological characteristics of the Evis MD Platinum Red system is virtually identical to the intended use and technological characteristics of the listed equivalent device. Any differences between the Evis MD Platinum Red and the equivalent device have no significant influence on safety or effectiveness of the Evis product.
7. Nonclinical Performance Data
The Evis MD Platinum Red was tested and complics with Electrical Safety and EMC testing, which include the requirements of IEC/EN/UL 60601-1 "Medical Electrical Equipment Part 1 - General Requirements for Safety" and was tested in accordance to Medical Directive 93/42/EEC - CSA 601.1, EMC Directive 2004/108/EC IEC/EN 60601-1-2 *Medical Electrical Equipment Part 1-2, General Requirements for Safety - Collateral Standard Electromagnetic Compatibility Requirements and Tests. I'CC 47CRF PT 18 Industrial, Scientific, and Medical Equipment. ICES 005 Radio Frequency Light Device
8. Conclusions
Based upon an analysis of the overall performance characteristics for the Evis MD Platinum Red Light Therapy, Ageless Beauty Corporation believes that no significant differences exist between this system and the predicate systems quoted, therefore, the Evis MD Platinum Red Light Therapy device does not impose any new safety or effectiveness concerns.
2
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
OCT 0 8 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ageless Beauty Corporation % Aesthetica-Tech Ms. Jill Creasy 675 Pine Street Elgin, Illinois 60123
Re: K082247 Trade/Device Name: Evis MD Platinum Red Light Therapy 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: September 19, 2008 Received: September 22, 2008
Dear Ms. Creasy:
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 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
1 . . . .
3
Page 2 - Ms. Jill Creasy
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Mark N Millerson
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 (if known): __ K082247
Device Name: Evis MD Platinum Red Light Therapy Indications for Use:
The Evis MD Platinum Red Light Therapy device is intended to provide light to the body.
Generally indicated to dermatology use for the treatment of superficial, benign vascular and pigmented lesions "such as but not limited to solar lentigines, sun spots, liver spots and age spots".
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR Part 801 Subpart D)
Over-The-Counter Use (21 CFR Part 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 R.P. Ryden for m
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
082247 510(k) Number
Page 1 of ____________________________________________________________________________________________________________________________________________________________________