(113 days)
Not Found
No
The device description and performance studies focus solely on the use of blue LED light therapy and user comprehension of instructions, with no mention of AI or ML.
Yes
The device is indicated to "treat mild to moderate acne on the face," which signifies a therapeutic purpose.
No
Explanation: The device is indicated for the treatment of mild to moderate acne using LED light therapy, not for diagnosing medical conditions.
No
The device description explicitly states it uses "Blue Light Emitting Diodes to provide LED Light therapy to the skin," indicating a hardware component responsible for emitting light. The performance studies also mention testing for compliance with hardware-related standards like IEC 60601-1 and IEC 62471.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat mild to moderate acne on the face." This is a therapeutic treatment applied directly to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device uses "Blue Light Emitting Diodes to provide LED Light therapy to the skin." This describes a physical therapy device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific substances (analytes) in a sample.
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition based on sample analysis.
The device is clearly intended for direct application to the skin for therapeutic purposes.
N/A
Intended Use / Indications for Use
Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.
Product codes
OLP
Device Description
The Pulsaderm ACE-All Blue is a device that uses Blue Light Emitting Diodes to provide LED Light therapy to the skin. Blue light is emitted for the treatment of mild to moderate acne.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
face
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
A lay-user study and self-selection study was conducted with Institutional Review Board (IRB) approval and oversight to determine if lay users could read the product labeling and then selfassess if the Pulsaderm ACE-ALL Blue would be beneficial for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that 98% of lay users were able to properly use the device by reading instructions in the user manual without any assistance.
Summary of Performance Studies
A lay-user study and self-selection study was conducted with Institutional Review Board (IRB) approval and oversight to determine if lay users could read the product labeling and then selfassess if the Pulsaderm ACE-ALL Blue would be beneficial for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that 98% of lay users were able to properly use the device by reading instructions in the user manual without any assistance.
In summary, the conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.
Key Metrics
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2016
Nutra Luxe MD, LLC Ms. Gloria Avendano Regulatory Affairs Manager 12801 Commonwealth Dr., Unit 5 Fort Myers, FL 33913
Re: K162371
Trade/Device Name: Pulsader ACE-All Blue 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: OLP Dated: October 31, 2016 Received: November 16, 2016
Dear Ms. Avendano
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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, Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): pending K162371
Device Name: Pulsaderm ACE-All Blue
Indications for Use:
Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.
Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
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510(k) Summary Pulsaderm ACE - All Blue
1. General Information
Submitter: NutraLuxe MD, LLC 12801 Commonwealth Dr. Unit 5 Fort Myers, FL 33913
Contact Person:
Gloria Avendano Regulatory Affairs Manager Nutra Luxe MD 12801 Commonwealth Dr. Unit 5 Fort Myers, FL 33913 Gloria@nutraluxemd.com
Summary Preparation Date: August 20th, 2016
2. Device
| Device Name: | Pulsaderm ACE - All Blue |
|---|---|
| Common/Usual Name: | Acne Light Therapy System |
| Classification Name: | Over-the-counter powered light based laser for acne |
| Classification Regulation: | 21CFR 878.4810 |
| Classification Panel: | General and Plastic Surgery |
| Product Code: | OLP |
3. Predicate Devices:
Pulsaderm ACE-All Blue is substantially equivalent to the following predicate devices;
| Device | 510(k) Number | Manufacturer |
|---|---|---|
| Nutra Light Blue | K132838 | Nutra Luxe MD, LLC |
| Tanda Mini Skincare System | K124042 | Syneron Beauty Inc. |
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4. Device Description:
The Pulsaderm ACE-All Blue is a device that uses Blue Light Emitting Diodes to provide LED Light therapy to the skin. Blue light is emitted for the treatment of mild to moderate acne.
5. Indications for use:
Pulsaderm ACE-A11 Blue is indicated to treat mild to moderate acne on the face.
6. Technological Characteristics and substantial equivalence:
Pulsaderm ACE-All Blue is substantially equivalent to Nutra Light Blue (K132838) and Tanda Mini Skin Care System (K124042). Pulsaderm ACE-All Blue is a smaller version of the predicate device Nutra Light Blue (K132838) and shares the same features and characteristics as the predicate. Pulsaderm ACE-All Blue uses the same technology to deliver blue light and same indications for use as the predicates. Pulsaderm ACE-All Blue uses the same dose rate and treatment regimen as Tanda Mini Skin Care System (K124042). Any minor technological differences between the Pulsaderm ACE-All Blue and the predicate devices raise no new issues of safety or effectiveness.
Comparison table:
| Device name | Pulsaderm ACE-All Blue | Nutra Light Blue | Tanda mini skin care
system |
|---------------------|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| 510(K) | Pending | K132838 | K124042 |
| Intended use | Indicated to treat
mild to moderate
acne on the face | Indicated to treat
dermatological
conditions. Specifically,
blue light modules are
indicated to treat mild to
moderate inflammatory
acne. | Indicated for over the
counter use for the
treatment of mild to
moderate acne |
| Energy type | Light Emitting diodes
(LED's) | Light Emitting diodes
(LED's) | Light Emitting diodes
(LED's) |
| OTC | Yes | Yes | Yes |
| Wavelength
(nm) | Blue light 415 +/-5 nm | Blue light 415 +/- 5 nm | Blue light 415+/- 5 nm |
| Dose Rate
mW cm2 | Blue light: 25 mW cm2 | Blue light: 75 mW cm2 | Blue light 22.4 mW cm2 |
| Dose
J/cm2 | 12 J/cm2 | 14 J/cm2 | 12 J/cm2 |
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7. Performance Data:
Performance testing was conducted and confirm compliance to design specifications; similar wavelength, output power and energy type as FDA cleared predicate devices. Pulsaderm ACE-All Blue has been tested and found in conformance with test standards: IEC 60601-1:2012, 60601-1-2:2014, and IEC 62471:2006. Biocompatibility testing to ISO 10993. Pulsaderm ACE-All Blue was designed and developed under a Risk Management System conforming to ISO 14971:2007.
8. Non clinical-testing
A lay-user study and self-selection study was conducted with Institutional Review Board (IRB) approval and oversight to determine if lay users could read the product labeling and then selfassess if the Pulsaderm ACE-ALL Blue would be beneficial for them to use. Study data was collected and demonstrated that the intended users of the device could successfully follow the instructions and use the device as intended. The performance data supplied in this 510(k) demonstrated that 98% of lay users were able to properly use the device by reading instructions in the user manual without any assistance.
In summary, the conclusion was that an average lay user can read and comprehend correctly the user manual and package labeling.
9. Conclusion
Based upon the analysis of the performance characteristics, safety characteristics and intended use for the Pulsaderm ACE-All Blue, Nutra Luxe MD, believes that no significant differences exist between this device and the predicates. Therefore, Substantial equivalence is requested.