SHASER V-MINI 2 is intended to provide phototherapeutic light to the body. It is also intended for removal of unwanted hair by using a selective photothermal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The Shaser V-MINI 2 is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Description

Shaser V-MINI 2 is an Over-The-Counter, Cordless, Rechargeable Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

AI/ML Overview

The provided text describes the Shaser V-MINI 2 Hair Removal System. The study conducted to support its clearance was focused on label comprehension and usability, not on the effectiveness of hair removal itself, which is typically established through clinical trials measuring hair reduction. Since the submission is for substantial equivalence to predicate devices, the hair removal efficacy data from prior submissions for similar devices are likely referenced.

Here's an analysis based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for this submission)	Reported Device Performance
Label Comprehension: Consumers' ability to understand instructions for safe and appropriate use.	"Sufficient label comprehension"
Usability: Consumers' ability to use the device safely in a simulated OTC home-use environment.	"Safe and appropriate use of the device"

Note: The provided submission focuses on the safety and usability of the device for over-the-counter use, especially regarding label comprehension. It does not provide specific quantitative acceptance criteria (e.g., minimum percentage of users understanding instructions) or detailed performance metrics relating to hair removal efficacy. The statement "The V-MINI 2 is a safe and effective device for the intended use" is a conclusion, not a performance metric from the described clinical tests. The efficacy claims (e.g., "permanent reduction in unwanted hair") rely on the substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Label Comprehension Test Set Sample Size: 150 subjects
Usability Test Set Sample Size: 123 subjects
Data Provenance: The document does not explicitly state the country of origin but implies the study was conducted to support FDA clearance in the United States. The studies appear to be prospective as they involved testing subjects' comprehension and usability. The populations included "low literacy subjects."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable for this type of study. The ground truth for label comprehension and usability is typically established by observing user behavior and understanding, not by expert consensus on a medical diagnosis or outcome. The evaluation would be done by study administrators observing and recording participant responses and actions.

4. Adjudication Method for the Test Set

Not specified or applicable in the traditional sense for these types of studies. Label comprehension and usability studies typically involve direct observation and structured questionnaires, where participant responses are recorded and analyzed. There's no mention of multiple reviewers adjudicating conflicting interpretations from the subjects.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Shaser V-MINI 2 is a hair removal device, and the described clinical performance data relates to label comprehension and usability, not diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "clinical performance data" for this submission are focused on the human interface with the device (label comprehension and usability) rather than the standalone performance of a complex algorithm or diagnostic output. The device itself (the Shaser V-MINI 2 Hair Removal System) operates independently, and the tests assessed how effectively users could operate it alone based on instructions. The device's "standalone performance" in terms of hair removal efficacy is implicitly handled by its substantial equivalence to predicate devices, where such efficacy data would have been established.

7. The Type of Ground Truth Used

For Label Comprehension: User understanding and correct verbalization/demonstration of instructions.
For Usability: Safe and appropriate physical interaction with the device as observed and assessed against predetermined safe/correct usage criteria.

8. The Sample Size for the Training Set

Not applicable. The described studies are for testing the device's usability and label comprehension. This is not an AI/algorithm development and validation study requiring a specific training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of this usability and label comprehension study for a physical device.

Summary

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510(K) Summary

FEB 12 2014

Submitter:	Shaser, Inc.10 Maguire RoadLexington. MA 02421
Contact:	Anthony BurnsSenior Director of Regulatory Affairs
Date Summary Prepared:	September 30, 2013
Device Trade Name:	Shaser V-MINI 2 Hair Removal System
Common Name:	Light Based Hair Removal Device
Classification Name:	Powered Light Based Non-Laser Surgical Instrument with ThermalEffect79-ONF, 21 CFR 878.4810
Equivalent Devices:	Shaser V-MINI Hair Removal System (K130015) and Shaser HRS2Rx Hair Removal System (K132266)
Device Description:	Shaser V-MINI 2 is an Over-The-Counter, Cordless, RechargeableLight-Based Hair Removal System. Emission activation is by fingerswitch. Device includes a limited life treatment head and batterycharger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger electricalrequirement is 115 VAC, 15A, 50-60 Hz, single phase.
Intended Use:	Removal of unwanted hair.
Indications For Use:	SHASER V-MINI 2 is an over the counter device intended to providephototherapeutic light to the body. It is also intended for removal ofunwanted hair by using a selective photothermal treatment. It is alsoindicated for the removal of unwanted body and/or facial hair in adultswith Fitzpatrick skin types I - IV. The Shaser V-MINI 2 is alsointended for permanent reduction in unwanted hair. Permanent hairreduction is defined as the long-term stable reduction in the number ofhairs regrowing when measured at 6, 9, and 12 months after thecompletion of a treatment regimen.
Comparison:	The Shaser V-MINI 2 has the same Intended Use, the same principleof operation, the same pulse energy range, and very similar wavelengthrange as the predicate devices.
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 OTC home-use environment.
	150 study subjects were tested for label comprehension and 123study subjects tested for usability. Both test populations included

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low literacy subjects.

The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device.

Conclusion:

The V-MINI 2 is a safe and effective device for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 12, 2014

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

Re: K133201

Trade/Device Name: Shaser V-MINI 2 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: November 12, 2013 Received: November 14, 2013

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 four d 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 or any is with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Anthony Burns

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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,

Felipe Aguel

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows a scattering of small, dark, irregularly shaped objects against a white background. The objects are distributed unevenly across the frame, with some clustering and others appearing isolated. Due to the lack of distinct features, it is difficult to determine the exact nature of these objects.

Indications for Use

510(k) Number (if known): K133201

Device Name: Shaser V-MINI 2

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Oggene 2014.02.10 12 12 12 25 -05'00'

(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number K133201_

Exhibit F (1 of 1)

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.