Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37

K170111 · Pulsaderm, LLC · OLP · May 8, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170111
• Device Name: Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
• Applicant: Pulsaderm, LLC
• Product Code: OLP · General, Plastic Surgery
• Decision Date: May 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Pulsaderm Acne Mask 28 and 37 are wearable light therapy devices for home use. Devices utilize light-emitting diodes (LEDs) to deliver low-power, non-coherent red (630 nm) and blue (440 nm) light to the skin. Powered by rechargeable Ni-MH batteries. Users operate the device independently for 10-minute daily sessions over a 30-day regimen. Light exposure targets acne lesions to provide therapeutic benefit. Device design allows for self-selection and self-administration by lay users based on provided labeling and instructions.

Clinical Evidence

No clinical efficacy trials performed. Evidence consists of bench testing for electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 62471) and biocompatibility (ISO 10993). A lay-user study and self-selection study were conducted to validate that users could correctly interpret labeling, self-assess suitability, and operate the device without assistance.

Technological Characteristics

Light-based acne treatment system using LEDs. Wavelengths: Red 630 +/- 5 nm, Blue 440 +/- 5 nm. Energy delivery: 20.44 J/cm² (Mask 28) and 22.72 J/cm² (Mask 37). Power source: Rechargeable Ni-MH batteries. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 10993, ISO 14971.

Indications for Use

Indicated for over-the-counter treatment of mild to moderate acne in the general population.

Regulatory Classification

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.

Predicate Devices

• Illumask Acne Light Therapy System (K123999)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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 [e-mail]

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.

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## 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<br>28 | Pulsaderm Acne Mask 37 | Illumask Acne Light Therapy |
|-------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Number | Pending | Pending | K123999 |
| Indications for Use | Intended for over the<br>counter use for the<br>treatment of mild to<br>moderate acne. | Intended for over the<br>counter use for the<br>treatment of mild to<br>moderate acne. | Intended to emit energy in the red<br>and blue region of the spectrum,<br>specifically indicated to treat mild to<br>moderate acne |
| Wavelength | Red: 630 +/- 5 nm<br>Blue: 440 +/-5 nm | Red: 630 +/- 5 nm<br>Blue: 440 +/-5 nm | Red: 630 nm +/- 5 nm<br>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<br>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<br>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.