SHASER V-MINI HAIR REMOVAL SYSTEM by SHASER, INC.

The SHASER HRS3 hair removal system is an over the counter device intended for removal of unwanted hair. It 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

Over-The-Counter, Cordless, Rechargable, Personal Light-Based Hair Removal System For Permanent Hair Reduction. Emission activation is by fingerswitch. Includes limited life treatment head and battery charger. Overall weight of the device is 0.45 Kg, and the size is 2.1 x 0.6 x 0.8 cm (HxWxD). Charger Electrical Requirement is 115 VAC, 15A, 50-60 Hz, single phase.

AI/ML Overview

This document describes a 510(k) submission for the Shaser V-MINI Hair Removal System. The information provided is primarily focused on the device's substantial equivalence to a predicate device and its intended use, rather than a detailed clinical study demonstrating its performance against specific acceptance criteria.

Therefore, many of the requested sections about clinical study details cannot be fully answered from the provided text.

Here is the information that can be extracted or reasonably inferred from the document regarding acceptance criteria and related studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of specific performance acceptance criteria for hair reduction or removal efficacy. Instead, it focuses on qualitative assessments related to label comprehension and usability for safe operation.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Label Comprehension	Sufficient understanding of Instructions For Use (IFU) by consumers, including low-literacy subjects.	"The results of the two tests confirms sufficient label comprehension"
Usability	Safe and appropriate use of the device by consumers, including low-literacy subjects, in a simulated OTC home-use environment.	"and safe and appropriate use of the device."
Functionality/Safety	The device performs as intended without unexpected issues in the test environment.	Confirmed by usability test; no adverse events or functionality issues reported in the summary.

Note: The primary "performance" claims for this device are "removal of unwanted hair" and "permanent reduction in unwanted hair" (defined as long-term stable reduction at 6, 9, and 12 months post-treatment). However, the provided document DOES NOT contain clinical data or acceptance criteria specifically measuring hair reduction efficacy. The "study" mentioned pertains to label comprehension and usability, not clinical effectiveness.

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

Sample size for Label Comprehension Test: 150 study subjects
Sample size for Usability Test: 123 study subjects
Data Provenance: The document does not explicitly state the country of origin. Given the company (Shaser, Inc.) and the submission to the FDA, it is highly likely that the study was conducted in the United States. The study was prospective in nature, as it involved subjects actively participating in tests.

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

This question is not applicable to the studies described. The studies were focused on consumer comprehension and usability, not on expert assessment of device efficacy against a ground truth (like pathology for disease). The "ground truth" for these studies would be whether the subjects correctly understood the label and could safely operate the device, as assessed by study administrators/observers, rather than independent experts establishing a medical ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For label comprehension and usability tests, the outcome is typically determined by structured observations, questionnaires, and task completion metrics, and there isn't usually a need for a separate adjudication panel in the way medical imaging studies use them.

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

No, an MRMC comparative effectiveness study was not done. The described studies are label comprehension and usability tests, not clinical efficacy trials involving human readers assessing outcomes. The device is a direct-to-consumer hair removal system, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical hair removal system, not an algorithm. The "standalone" performance here would refer to its physical function and safety, which was assessed through the usability test involving human interaction.

7. The Type of Ground Truth Used

For the label comprehension and usability tests, the "ground truth" was established by the study protocol's definition of correct understanding and safe/appropriate usage. This would typically involve:

For Label Comprehension: Correct answers to questions about the instructions for use.
For Usability: Successful and safe completion of tasks with the device according to predefined criteria, observed by study personnel.

There was no "expert consensus," "pathology," or "outcomes data" in the medical sense used to establish ground truth for these specific tests.

8. The Sample Size for the Training Set

This concept is not applicable here. The described studies are consumer-facing validation tests for label comprehension and usability, not a development of an algorithm that requires a training set. The device itself is electro-optical, not an AI/ML algorithm.

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

This question is not applicable, as there was no "training set" in the context of algorithm development.

Summary

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510(K) Summary

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Shaser, Inc.10 Maguire RoadJUN 1 3 2013Building ILexington, MA 02421
Anthony BurnsSr. Director of Regulatory Affairs
December 31, 2012
Shaser V-MINI Hair Removal System
Light based hair removal device
Powered Light Based Non-Laser Surgical Instrument with ThermalEffect. Product Code ONF
Shaser HRS2 Hair Removal System
Over-The-Counter, Cordless, Rechargable, Personal Light-Based HairRemoval System For Permanent Hair Reduction
Emission activation is by fingerswitch. Includes limited life treatmenthead and battery charger. Overall weight of the device is 0.45 Kg, andthe size is 2.1 x 0.6 x 0.8 cm (HxWxD).
Charger Electrical Requirement is 115 VAC, 15A, 50-60 Hz, singlephase.
The SHASER V-MINI hair removal system is an over the counterdevice intended for removal of unwanted hair. It is also intended forpermanent reduction in unwanted hair. Permanent hair reduction isdefined as the long-term stable reduction in the number of hairsregrowing when measured at 6, 9, and 12 months after the completionof a treatment regimen.
The Shaser V-MINI Hair Removal System has the same indication foruses, the same principle of operation, the same pulse energy range andwavelength range as the predicate device.
Nonclinical Performance Data:none
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 subject were tested for label comprehension and 123study subjects tested for usability. Both test populations includedlow literacy subjects.The results of the two tests confirms sufficient label comprehensionand safe and appropriate use of the device.

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Conclusion:

The Shaser V-MINI Hair Removal System is a safe and effective device for the intended uses.

Additional Information:

None

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 13, 2013

Shaser, Inc. % Ms. Sarah Hackett 10 Maguire Road, Suite 120 Building One Lexington, Massachusetts 02421

Re: K130015

Trade/Device Name: Shaser V-Mini Hair Removal System 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: May 06, 2013 Received: May 08, 2013

Dear Ms. Hackett:

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

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Page 2 - Ms. Sarah Hackett

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Industrv/default.htm.

Sincerely yours,

David Krause -S

for Mark N. Melkerson Acting 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):

Device Name: _ Shaser V-MINI Hair Removal System

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) OR

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

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

Neil R Ogden 2013.06.11 16:24:42 -04'00'

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

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.