The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Device Description

Shaser Skin Beauty Intense Pulsed Light System Family For Acne is an Over-The-Counter, Light-Based Acne Clearing Device. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger/AC cord. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. The Principle of Operation is both photochemical and photothermal. The Mechanism of Action is to stimulate oxygen production which attacks p.acne and to reduce inflammation due to acne.

AI/ML Overview

The Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282) is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific reduction percentage in acne). Instead, the clinical performance data focuses on label comprehension and usability to ensure safe and appropriate use of the device by consumers in a home setting.

Acceptance Criteria Category	Specific Criteria (Implicitly based on stated successful outcomes)	Reported Device Performance (Summary from submission)
Label Comprehension	Consumers can understand the instructions for use.	Confirmed sufficient label comprehension.
Device Usability	Consumers can safely and appropriately use the device in a simulated home-use environment.	Confirmed safe and appropriate use of the device.
Nonclinical Performance	Device meets performance verification and electrical safety testing standards.	Bench testing for performance verification and electrical safety testing was conducted successfully.

2. Sample Size and Data Provenance for Test Set

Sample Size: 84 study subjects were tested for label comprehension and usability.
Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "simulated home-use environment," implying a prospective study design for the usability and comprehension aspects.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or disease diagnosis. The assessments were focused on consumer understanding and ability to use the device, rather than expert diagnostic accuracy. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method (Test Set)

No adjudication method is described, as the studies conducted focused on label comprehension and usability by the subjects themselves, rather than expert assessment of an outcome requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The study focused on consumer (user) performance in understanding and operating the device, not on diagnostic accuracy or comparison of human readers with and without AI assistance for acne diagnosis.

6. Standalone Performance (Algorithm Only)

The device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its physical operation and user interaction.

7. Type of Ground Truth Used (Test Set)

For the clinical performance data presented (label comprehension and usability), the "ground truth" was established by observing and evaluating the subjects' ability to understand the instructions and use the device correctly and safely. This is an assessment of human behavior and understanding in relation to the device, rather than a medical ground truth (e.g., pathology, clinical outcomes, expert consensus on disease state).

8. Sample Size for Training Set

The document describes a medical device study for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device and verifying safety and effectiveness through non-clinical and clinical performance testing. This is not a machine learning or AI algorithm submission that would have a distinct "training set." Therefore, information on the sample size for a training set is not applicable.

9. How Ground Truth for Training Set was Established

As there is no "training set" in the context of an AI algorithm, this question is not applicable.

Summary

{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 the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping each other, suggesting a sense of community and care.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2015

Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs 10 Maguire Road Lexington, Massachusetts 02421

Re: K150282

Trade/Device Name: Shaser Skin Beauty Intense Pulsed Light System Family for Acne 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: ONF Dated: April 30, 2015 Received: May 4, 2015

Dear Mr. Burns:

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 -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K150282

Device Name

Shaser Skin Beauty Intense Pulsed Light System Family for Acne

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(K) Summary

Submitter:	Shaser, Inc.10 Maguire RoadLexington, MA 02421
Contact:	Anthony BurnsSenior Director of Regulatory Affairs
Date Summary Prepared:	January 30, 2015
Device Trade Name:	Shaser Skin Beauty Intense Pulsed Light System Family For Acne
Common Name:	Light Based Acne Clearing Device
Classification Name:	Powered Light Based Non-Laser Surgical Instrument with ThermalEffect79-ONF, 21 CFR 878.4810
Equivalent Devices:	Shaser Skin Beauty Intense Pulsed Light System Family (K141583)CLRS Technology Corp. CLARO (K090744)
Device Description:	Shaser Skin Beauty Intense Pulsed Light System Family For Acne isan Over-The-Counter, Light-Based Acne Clearing Device. Emissionactivation is by finger switch. Device includes a limited life treatmenthead and battery charger/AC cord. Electrical requirement is 115 VAC,15A, 50-60 Hz, single phase.The Principle of Operation is both photochemical and photothermal.The Mechanism of Action is to stimulate oxygen production whichattacks p.acne and to reduce inflammation due to acne.
Intended Use:	Treatment of Acne.
Indications For Use:	The Shaser Skin Beauty Intense Pulsed Light System Family for Acneis an over-the-counter home use device intended to providephototherapeutic light to the body. It is also indicated for thetreatment of individual acne pimples in persons with mild to moderateinflammatory acne.
Comparison:	The Shaser Skin Beauty Intense Pulsed Light System Family For Acnehas the same principle of operation and light source, and very similarwavelength range and pulse energy as the predicate devices. Theproposed device has the same Intended Use as the CLARO predicatedevice.
Nonclinical Performance Data:	Bench testing for performance verification and electrical safety testing.
Clinical Performance Data:	Label comprehension and usability test of consumers' ability tounderstand the instructions for use and to evaluate their ability to usethe device safely in a simulated home-use environment.• 84 study subjects were tested for label comprehension and forusability. The test populations included low literacy subjects.The results of the two tests confirms sufficient label comprehensionand safe and appropriate use of the device.
Conclusion:	The Shaser Skin Beauty Intense Pulsed Light System Family For Acneis a safe and effective device for the intended use.
Additional Information:	None

Exhibit E (1 of 2)

{4}------------------------------------------------

{5}------------------------------------------------

TABLE OF COMPARATIVE FEATURES

	Proposed 510(k) Device	Predicate Device 510(k)K090744	Predicate Device510(k) K141583
Manufacturer	Shaser, Inc.	CLRS Technology Corp.	Shaser, Inc.
Trade Name	Shaser Skin Beauty Intense PulsedLight System Family for Acne	CLARO	Shaser Skin Beauty Intense Pulsed Light SystemFamily
Intended Use	Acne Clearing Device	Acne Clearing Device	Removal of Unwanted Hair
Indications	The Shaser Skin Beauty IntensePulsed Light System Family forAcne is an over-the-counter homeuse device intended to providephototherapeutic light to the body,specifically indicated for thetreatment of individual acnepimples in persons with mild tomoderate inflammatory acne.	The CLARO is indicated forthe treatment of individualacne pimples in persons withmild to moderateinflammatory acne.	The Shaser Skin Beauty Intense Pulsed Light SystemFamily is an over-the-counter home use deviceintended to provide phototherapeutic light to thebody. It is also intended for removal of unwanted hairby using a selective photothermal treatment. It is alsoindicated for the removal of unwanted body and/orfacial hair in adults with Fitzpatrick skin types I – IV.The Shaser Skin Beauty Intense Pulsed Light SystemFamily is also intended for permanent reduction inunwanted hair. Permanent hair reduction is defined asthe long-term stable reduction in the number of hairsregrowing when measured at 6, 9, and 12 monthsafter the completion of a treatment regimen.
'Use'Classification	OTC	OTC	OTC
DeviceClassification	Class II	Class II	Class II
Device Type	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light
	Proposed 510(k) Device	Predicate Device510(k) K090744	Predicate Device510(k) K141583
Wavelength (nm)	400 - 1100nm	400 - 1100nm	400 - 1200nm
Max. Fluence(J/cm²)	6.0	6.0	10
Spot Size (cm²)	2.0	1.0	2.0
Pulse Width (s)	6	6	<.2
Source Energy	AC Mains/Battery	Battery	AC Mains/Battery
User Interface	LCD display with text and graphics/LED Indicator lights	LED Indicator lights	LCD display with text and graphics /LEDIndicator lights
ControlMechanism	Microprocessor based	Non-Microprocessor based	Microprocessor based
TreatmentRegime	1 application = 6 seconds	1 application = 6 seconds	1 application < .2 seconds
	1 Treatment = 2 applications	1 Treatment = 2 applications	1 Treatment = 1 application
	No more treatments than:1 every 8 hours4 in a seven day period.	No more treatments than:1 every 8 hours4 in a seven day period.	No more treatments than:1 every two weeks.

{6}------------------------------------------------

TABLE OF COMPARATIVE FEATURES

Exhibit C (2 of 2)

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.