(69 days)
The Evis MD Platinum Blue Light Therapy device is intended to provide light to the body. Generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.
The Evis MD Platinum Blue Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand hold device contains the power supplies and a built in timed sound signaling with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for Blue is 41.5 +/- 5 nm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Evis MD Platinum Blue Light Therapy device:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, the submission focuses primarily on substantial equivalence to a predicate device rather than presenting specific performance metrics against defined acceptance criteria for clinical effectiveness.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Electrical Safety | Complies with IEC/EN/UL 60601-1, CSA 601.1 |
| EMC (Electromagnetic Compatibility) | Complies with IEC/EN 60601-1-2, FCC 47CRF PT 18, ICES 005 | |
| Effectiveness | Equivalence to predicate device for treating mild to moderate inflammatory acne vulgaris | "virtually identical to the intended use and technological characteristics of the listed equivalent devices." "no significant differences exist between this system and the predicate systems quoted" |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not describe a clinical study with a "test set" in the traditional sense of evaluating a device's clinical performance. The submission relies on a comparison to a predicate device and non-clinical engineering tests.
Therefore, there is no information on:
- Sample size used for the test set.
- Data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
As no clinical study with a "test set" is described, there is no mention of experts or the establishment of ground truth in this context within the provided document.
4. Adjudication Method for the Test Set:
Since there is no described clinical study involving a "test set" and human assessment of outcomes, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No MRMC comparative effectiveness study is described in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence through technological comparison and non-clinical testing, not on quantifying improvement with AI assistance (as this is not an AI device).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is not an algorithm or AI system. It is a physical light therapy device. Therefore, the concept of "standalone (algorithm only)" performance does not apply.
7. The Type of Ground Truth Used:
For the clinical claim of effectiveness (treating mild to moderate inflammatory acne vulgaris), the "ground truth" implicitly relies on the established effectiveness of the predicate device (Tanda Skincare System Blue, K070185). The current device is deemed substantially equivalent in its intended use and technological characteristics.
For the non-clinical performance, the ground truth is established by validated engineering standards and regulations (IEC/EN/UL 60601-1, IEC/EN 60601-1-2, FCC 47CRF PT 18, ICES 005).
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
Summary of the Study:
The provided document, a 510(k) Summary, describes the submission for the Evis MD Platinum Blue Light Therapy device. The "study" presented here is primarily a non-clinical performance evaluation and a substantial equivalence argument based on comparison to a legally marketed predicate device.
- Non-Clinical Performance Data: The device underwent testing to ensure compliance with electrical safety (IEC/EN/UL 60601-1, CSA 601.1) and electromagnetic compatibility (IEC/EN 60601-1-2, FCC 47CRF PT 18, ICES 005) standards. These tests verify the device's technical specifications and safety aspects.
- Substantial Equivalence Argument: The core of the submission for effectiveness relies on demonstrating that the Evis MD Platinum Blue Light Therapy device is "virtually identical" to the predicate device (Tanda Skincare System Blue, K070185) in its intended use and technological characteristics. The submitter asserts that "Any differences...have no significant influence on safety or effectiveness." This approach means that the device's effectiveness for treating mild to moderate inflammatory acne vulgaris is inferred from the established effectiveness of the predicate.
In essence, the "study" for this 510(k) is a desktop comparison and engineering validation, rather than a prospective clinical trial with human subjects.
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OCT 1 5 2008
FDA 510K Summary of Safety and Effectiveness for EVIS MD PLATINUM BLUE LIGHT THERAPY
1. General Information
| Submitter: | Ageless Beauty Corporation28470 Avenue StanfordSuite 350Valencia, CA 91355Office: +1 877 629-4429Fax: +1 661 295-5088 |
|---|---|
| Contact Person: | C/O Jill CreasyAesthetica-Tech675 Pine StreetElgin, IL 60123847-429-9631contact@aestheticatech.com |
| Summary Preparation Date: | August 4, 2008 |
Device Name
| Device Name: | Evis MD Platinum BLUE Light Therapy |
|---|---|
| Classification Name: | Laser Surgical instrument for use in General, Plastic Surgery andin 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 Blue Light Therapy device is substantially equivalent to the Tanda Skincare System Blue (K070185)
Device Description 4.
The Evis MD Platinum Blue Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand hold device contains the power supplies and a built in timed sound signaling with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for Blue is 41.5 +/- 5 nm.
યંત્ Intended Use and Indications:
The Evis MD Platinum Blue Light Therapy is intended to provide light to the body.
Generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.
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KU82232
Comparison of Technological Differences: 6.
The intended use and technological characteristics of the Evis MD Platinum Blue system are virtually identical to the intended use and technological characteristics of the listed equivalent devices. Any differences between the Evis MD Platinum Blue and the equivalent device have no significant influence on safety or effectiveness of the Evis product.
7. Nonclinical Performance Data
The Evis MD Platinum Blue was tested and complies 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. FCC 47CRF PT 18 Industrial, Scientific, and Medical Equipment. ICES 005 Radio Frequency Light Device
Conclusions 8.
Based upon an analysis of the overall performance characteristics for the Evis MD Platinum Blue Light Therapy. Ageless Beauty Corporation believes that no significant differences exist between this system and the predicate systems quoted, therefore, the Evis MD Platinum Blue Light Therapy device does not impose any new safety or effectiveness concerns.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2008
Ageless Beauty Corporation % Aesthetica-Tech Ms. Jill Creasy 675 Pine Street Elgin, Illinois 60123
Re: K082232 Trade/Device Name: Evis MD Platinum Blue 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 22, 2008 Received: September 24, 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
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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 vours.
Mark N Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Evis MD Platinum Blue Light Therapy Indications for Use:
The Evis MD Platinum Blue Light Therapy device is intended to provide light to the body.
- Generally indicated to treat dermatological conditions and specifically indicated to treat mild to l. moderate inflammatory acne vulgaris.
AND/OR Prescription Use X (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)
for D.h. Del D.r
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K082232
§ 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.