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.

AI/ML Overview

The provided document is a 510(k) summary for the Pulsaderm Acne Mask 28 and 37. It describes the device, its intended use, and its substantial equivalence to a predicate device (Illumask Acne Light Therapy System, K123999). However, it does not contain information related to specific acceptance criteria for device performance in terms of clinical effectiveness (e.g., reduction in acne lesions) nor a study proving the device meets such criteria.

The "Performance Data" section primarily addresses compliance with electrical, electromagnetic compatibility, photobiological safety, and biocompatibility standards, as well as a lay-user study for usability and self-selection. It does not provide data on the clinical efficacy of the device in treating acne.

Therefore, many of the requested details cannot be extracted from this document, as the focus is on demonstrating substantial equivalence through technical characteristics and safety, rather than presenting clinical trial results against pre-defined efficacy acceptance criteria.

Here's an attempt to answer the questions based only on the provided text, with clear indications where information is not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific percentage reduction in acne lesions) for the Pulsaderm Acne Mask. The "acceptance" in this context refers to demonstrating substantial equivalence to the predicate device and compliance with safety standards and design specifications.
Reported Device Performance: The document reports on compliance with various safety standards and the results of a lay-user study for usability. It does not report clinical performance metrics for treating acne.

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated for Clinical Efficacy)	Reported Device Performance
Clinical Efficacy	Not explicitly stated in terms of a quantitative clinical outcome (e.g., X% reduction in acne lesions). Implied acceptance is substantial equivalence to predicate which is "indicated to treat mild to moderate acne."	No clinical efficacy data (e.g., reduction in acne) is reported in this document. The device shares similar technical characteristics (wavelength, energy, treatment protocol) with the predicate device, which is indicated for "mild to moderate acne."
Electrical Safety	Compliance with IEC 60601-1	"tested and found in conformance with test standards: IEC 60601-1"
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	"tested and found in conformance with test standards: IEC 60601-1-2"
Photobiological Safety	Compliance with IEC 62471	"tested and found in conformance with test standards: IEC 62471"
Biocompatibility	Compliance with ISO 10993	"Biocompatibility testing to ISO 10993."
Usability/Self-Selection	Lay users can read labeling, self-assess benefits, and use the device as intended.	"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... and properly use the device by reading instructions in the user manual without any assistance."
Quality Management System	Conforming to ISO 14971	"designed and developed under a quality management system conforming to ISO 14971."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: For the lay-user study, the specific number of participants is not provided. It refers to "the majority of lay users."
Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective). However, the study was conducted with IRB approval and oversight, implying a prospective study design for the usability testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: This question is typically relevant for studies involving expert review of objective data (e.g., medical images). The lay-user study described here focused on user comprehension and device operation, not expert-adjudicated clinical outcomes. There is no mention of experts establishing a "ground truth" in the clinical sense within this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: As in point 3, this refers to expert review processes, which are not described for the studies mentioned in this document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No: The document does not describe an MRMC comparative effectiveness study, nor does it involve AI assistance for human readers. This device is a light therapy mask, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This refers to the performance of an algorithm without human intervention, typically in AI/diagnostic device contexts. The Pulsaderm Acne Mask is a physical medical device for treatment, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the lay-user study, the "ground truth" was whether users could successfully read instructions, self-select for use, and operate the device as intended. This was assessed by the study design and likely recorded through observations, questionnaires, or task completion metrics, overseen by an IRB. It does not involve expert consensus, pathology, or clinical outcomes data in the traditional sense for effectiveness.
For clinical efficacy (treating acne), no such ground truth or study is described in this document. The claim of "treatment of mild to moderate acne" is based on substantial equivalence to the predicate device, which presumably demonstrated efficacy in its own submission.

8. The sample size for the training set

Not Applicable / Not Provided: This question usually applies to machine learning models. No training set is mentioned as this is a physical light therapy device.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: As in point 8, this is not relevant to the information provided about the Pulsaderm Acne Mask.

Summary

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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 (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:

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 Mask28	Pulsaderm Acne Mask 37	Illumask Acne Light Therapy
510 (k) Number	Pending	Pending	K123999
Indications for Use	Intended for over thecounter use for thetreatment of mild tomoderate acne.	Intended for over thecounter use for thetreatment of mild tomoderate acne.	Intended to emit energy in the redand blue region of the spectrum,specifically indicated to treat mild tomoderate acne
Wavelength	Red: 630 +/- 5 nmBlue: 440 +/-5 nm	Red: 630 +/- 5 nmBlue: 440 +/-5 nm	Red: 630 nm +/- 5 nmBlue: 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 deliveredper 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 Treatmentsrequired	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.

Regulation Number and Section

§ 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.