(116 days)
Not Found
No
The summary describes a light therapy device for acne treatment and does not mention any AI or ML components or functionalities.
Yes
The device is described as treating "mild to moderate acne," which constitutes a therapeutic use.
No
Explanation: The device is intended for the treatment of mild to moderate acne, not for diagnosing it. Its function is to apply light therapy, not to identify or characterize a medical condition.
No
The device description explicitly states that the device uses Light Emitting Diodes (LEDs) and is powered by rechargeable batteries, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Pulsaderm Acne Mask uses light therapy applied directly to the skin to treat acne. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is for the "treatment of mild to moderate acne," which is a therapeutic application, not a diagnostic one.
The information provided clearly describes a device that applies energy to the body for a therapeutic purpose, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
The Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are intended for over the counter use for the treatment of mild to moderate acne.
Product codes (comma separated list FDA assigned to the subject device)
OLP
Device Description
Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are class II Medical Devices that use Light Emitting Diodes to apply low power monochromatic and non-coherent light in the red and blue range, to treat mild to moderate acne. The devices are powered by Ni-MH rechargeable batteries.
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
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
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 self-assess if the Pulsaderm Acne Mask 28 and 37 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 the majority of lay users were able to properly self-select themselves using the majority of lay users were able to properly use the device by reading instructions in the user manual without any assistance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted and confirm compliance to design specifications; similar wavelength, energy type and safety characteristics.
Pulsaderm Acne Masks 28 and Pulsaderm Acne Mask 37 were tested and found in conformance with test standards: IEC 60601-1, IEC 60601-1-2, and IEC 62471. Biocompatibility testing to ISO 10993.
Pulsaderm Acne Mask 28 and Acne Mask 37 were designed and developed under a quality management system conforming to ISO 14971.
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 self-assess if the Pulsaderm Acne Mask 28 and 37 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 the majority of lay users were able to properly self-select themselves using the majority 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 (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
Image /page/0/Picture/2 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 to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2017
Pulsaderm LLC Gloria Avendano Regulatory Affairs Manager 12801 Commonwealth Dr. Units 2-6 Fort Myers, Florida 33913
Re: K170111
Trade/Device Name: Pulsaderm Acne Mask 28, Pulsaderm Acne Mask 37 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: April 10, 2017 Received: April 11, 2017
Dear Gloria 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
1
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 of medical devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Jennifer R. Stevenson -S
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) K170111
Device Name
Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37
Indications for Use (Describe)
The Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are intended for over the counter use for the treatment of mild to moderate acne.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Pulsaderm Acne Mask 28, Pulsaderm Acne Mask 37
1. General Information
Submitter: Pulsaderm LLC 12801 Commonwealth Dr. Units 2-6 Fort Myers, FL 33913
Contact Person: Gloria Avendano Regulatory Affairs Manager Pulsaderm LLC 239-208-7549 Gloria@pulsaderm.com
Summary Preparation Date: December 1st, 2016
2. Device
| Device Name: | Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 |
|---|---|
| Common/Usual Name: | Acne Light Therapy System |
| Classification Name: | Over the Counter powered Light Based Laser for Acne |
| Classification Regulation: | 21 CFR 878.4810 |
| Classification Panel: | General and Plastic Surgery |
| Code: | OLP |
| Device Class: | II |
3. Predicate Devices:
| Device Name | K Number | Manufacturer |
|---|---|---|
| Illumask Acne Light Therapy System | K123999 | La Lumiere, LLC |
4. Device Description:
Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are class II Medical Devices that use Light Emitting Diodes to apply low power monochromatic and non-coherent light in the red and blue range, to treat mild to moderate acne. The devices are powered by Ni-MH rechargeable batteries.
5. Indications for Use:
The Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are intended for over the counter use for the treatment of mild to moderate acne.
4
6.Technological Characteristics and substantial equivalence:
Pulsaderm Acne Mask 28 and Acne Mask 37 share the same methods of operation, similar indications for use and similar treatment regimen as predicate K123999.
| Device Name | Pulsaderm Acne Mask
28 | Pulsaderm Acne Mask 37 | Illumask Acne Light Therapy |
|-------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number | Pending | Pending | K123999 |
| Indications for Use | Intended for over the
counter use for the
treatment of mild to
moderate acne. | Intended for over the
counter use for the
treatment of mild to
moderate acne. | Intended to emit energy in the red
and blue region of the spectrum,
specifically indicated to treat mild to
moderate acne |
| Wavelength | Red: 630 +/- 5 nm
Blue: 440 +/-5 nm | Red: 630 +/- 5 nm
Blue: 440 +/-5 nm | Red: 630 nm +/- 5 nm
Blue: 440 +/- 5 nm |
| OTC/Prescription | ОТС | OTC | OTC |
| Waveform | Constant | Constant | Constant |
| Rechargeable | Yes, Ni-MH Batteries | Yes, Ni-MH Batteries | NO |
| Number of LED Diodes | 28 | 37 | 21 |
| Total energy delivered
per treatment session | 20.44 j/cm² | 22.72 j/cm² | 21.94 j/cm² |
| Treatment protocol | 10 minutes everyday | 10 minutes everyday | 10 minutes everyday |
| Total Treatments
required | 30 | 30 | 30 |
The reference table below shows that the devices share similar output and technology characteristics
7. Performance Data:
Performance testing was conducted and confirm compliance to design specifications; similar wavelength, energy type and safety characteristics.
Pulsaderm Acne Masks 28 and Pulsaderm Acne Mask 37 were tested and found in conformance with test standards: IEC 60601-1, IEC 60601-1-2, and IEC 62471. Biocompatibility testing to ISO 10993.
Pulsaderm Acne Mask 28 and Acne Mask 37 were designed and developed under a quality management system conforming to ISO 14971.
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 self-assess if the Pulsaderm Acne Mask 28 and 37 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 the majority of lay users were able to properly self-select themselves using the majority 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 Acne Mask 28 and Acne Mask 37, Pulsaderm LLC believes that no significant differences exist between these devices and the predicate K123999. Therefore, Pulsaderm Acne Mask 28 and Acne Mask 37 are substantially equivalent to the predicate.