SHASER V-MINI RX by SHASER, INC.

The Shaser V-MINI RX Hair Removal System is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. It is also intended for removal of unwanted hair by using a selective photothermal treatment. The Shaser V-MINI RX Hair Removal System is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX Hair Removal System 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 RX is an IPL device with a wavelength range of 400- 1200 nm. The proposed device removes hair by way of Selective Photothermolysis; the preferential thermal treatment of target tissue without collateral effect of surrounding tissue. The pulsed light heats the hair bulb which disables hair growth. The proposed device is intended for males and females to remove unwanted hair from body sites (legs, arms, chest, underarms, stomach, and bikini line) and from facial sites (chin, cheek, chin, neck, side burns, and above the lips). The V-MINI RX is a battery powered, portable device. Electrical requirement (battery charger) is 115 VAC, 15A, 50-60 Hz, single phase.

AI/ML Overview

Here's an analysis of the provided text regarding the Shaser V-MINI RX device's acceptance criteria and supporting studies:

Table of acceptance criteria and reported device performance:

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a table format. The "Intended Use" section describes the device's purpose, including "permanent reduction in unwanted hair," defined as "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." However, there are no numerical thresholds (e.g., "at least 50% reduction") provided as acceptance criteria, nor are there any corresponding performance results from a study presented to demonstrate that these criteria were met.

Instead, the submission relies on the concept of "substantial equivalence" to predicate devices (Shaser V-MINI, Radiancy SpaTouch, Radiance SkinStation) rather than presenting new performance data against specific, pre-defined acceptance criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document explicitly states: "Clinical Performance Data: None" and "Nonclinical Performance Data: None". This indicates that no new test set data was generated or analyzed for this submission. The basis for approval is solely substantial equivalence to predicate devices.
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):

As no new clinical or nonclinical performance data was presented for the Shaser V-MINI RX, there were no experts involved in establishing ground truth for a test set within this specific 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Since no new test set data was presented, no adjudication method was used.
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 MRMC comparative effectiveness study was done. The device is a light-based hair removal instrument, not an AI diagnostic or assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical light-based hair removal instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

No new ground truth was established for the Shaser V-MINI RX as no new clinical or nonclinical studies were performed for this submission. The approval relies on the ground truth (safety and efficacy) established for the predicate devices.
The sample size for the training set:

Not applicable. The device is not an AI algorithm that requires a training set.
How the ground truth for the training set was established:

Not applicable, as there is no training set for this device.

Summary of the Acceptance Criteria and Study:

The 510(k) submission for the Shaser V-MINI RX does not present new acceptance criteria or new studies proving the device meets them. Instead, the basis for clearance is Substantial Equivalence to legally marketed predicate devices (Shaser V-MINI, Radiancy SpaTouch, Radiance SkinStation).

The argument made is that the Shaser V-MINI RX has the "same intended use, the same principle of operation and method of action, similar pulse energy range, and very similar wavelength range" as the predicates. The submission explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None," indicating that no new studies were conducted to generate data for this specific device. The differences cited for the V-MINI RX (larger spot size, higher maximum energy level, wider wavelength range) are asserted not to raise "new issues of safety and efficacy."

Therefore, the "acceptance criteria" were met by demonstrating that the device is sufficiently similar to previously approved devices, implying it shares their established safety and efficacy profile, rather than by showing performance against specific, pre-defined metrics in a new study.

Summary

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510(K) Summary

Submitter:	Shaser, Inc.10 Maguire RoadLexington, MA 02421781-995-2246	NOV 2 6 2013
Contact:	Anthony Burns, Senior Director of Regulatory Affairs
Summary Prepared:	July 12, 2013
Device Trade Name:	Shaser V-MINI RX
Common Name:	Light Based Hair Removal Device
Classification Name:	Product Code ONF: Powered Light Based Non-Laser SurgicalInstrument with Thermal Effect
Equivalent Device:	Shaser V-MINI (K130015), Radiancy SpaTouch (K020856), RadianceSkinStation (K051671)
Device Description:	Shaser V-MINI RX is an IPL device with a wavelength range of 400-1200 nm. The proposed device removes hair by way of SelectivePhotothermolysis; the preferential thermal treatment of target tissuewithout collateral effect of surrounding tissue. The pulsed light heatsthe hair bulb which disables hair growth. The proposed device isintended for males and females to remove unwanted hair from bodysites (legs, arms, chest, underarms, stomach, and bikini line) and fromfacial sites (chin, cheek, chin, neck, side burns, and above the lips).The V-MINI RX is a battery powered, portable device. Electricalrequirement (battery charger) is 115 VAC, 15A, 50-60 Hz, singlephase.
Intended Use:	The Shaser V-MINI RX Hair Removal System is intended to providephototherapeutic light to the body and is generally indicated to treatdermatological conditions. It is also intended for removal of unwantedhair by using a selective photothermal treatment. The Shaser V-MINIRX Hair Removal System is indicated for patient removal ofunwanted hair by using a selective photothermal treatment under thedirection of a physician, after training by a healthcare professional. Itis also indicated for the removal of unwanted body and/or facial hairin adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RXHair Removal System is also intended for permanent reduction inunwanted hair. Permanent hair reduction is defined as the long-termstable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a treatment regimen.
TechnicalCharacteristics:	The Shaser V-MINI RX is the exact same device as the V-MINI predicate device; with the same technical characteristics – same design (with the exception of a larger spot size, higher maximum energy level, and wider wavelength range), the same components and materials, powered by the same energy source. None of these differences raises new issues of safety and efficacy.
Comparison:	The Shaser V-MINI RX has the same intended use, the same principle of operation and method of action, similar pulse energy range, and very similar wavelength range as the SkinStation and V-MINI predicate devices.
NonclinicalPerformance Data:	None.
Clinical PerformanceData:	None
Conclusion:	The V-MINI RX is a safe and effective device for the intended use.
Additional Information:	None

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the figure. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

November 26, 2013

Rc: K132170

Trade/Device Name: Shaser V-MINI RX 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: September 18, 2013 Received: September 19, 2013

Dear Mr. Burns:

We have reviewed your Section 510(k) premarket notification of intent to market the device worked 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 enacunent 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). and Cosmetic Act (110.) market the device, subject to the general controls provisions of the Act. The r ou may sherelevel manns of the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 that 115A has made a 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 - Mr. Anthony Burns

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,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director

For

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): K132170

Device Name: __ Shaser V-MINI RX

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) OR

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)

Joshua C. Nipper -S

(Division Sign-Off) for BSA

Division of Surgical Devices

510(k) Number K132170

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.