SHASER V-MINI RX

K132170 · Shaser, Inc. · ONF · Nov 26, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K132170
• Device Name: SHASER V-MINI RX
• Applicant: Shaser, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Shaser V-MINI RX is a portable, battery-powered IPL device for hair removal. It emits pulsed light (400-1200 nm) to perform selective photothermolysis; light energy heats hair bulbs to disable growth. Used by patients at home under physician direction following professional training. Device output is light pulses applied to skin; clinical benefit is permanent hair reduction. No complex software or algorithmic processing described.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable, battery-powered IPL device. Wavelength range: 400-1200 nm. Principle: Selective photothermolysis. Components and materials are identical to the V-MINI predicate, with modifications to spot size, maximum energy level, and wavelength range. Electrical requirement: 115 VAC, 15A, 50-60 Hz battery charger.

Indications for Use

Indicated for removal of unwanted body (legs, arms, chest, underarms, stomach, bikini line) and facial (chin, cheek, neck, sideburns, above lips) hair in adults with Fitzpatrick skin types I-VI. Requires physician direction and professional training.

Regulatory Classification

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.

Predicate Devices

• Shaser V-MINI (K130015)
• Radiancy SpaTouch (K020856)
• Radiance SkinStation (K051671)

Submission Summary (Full Text)

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## 510(K) Summary

| Submitter: | Shaser, Inc.<br>10 Maguire Road<br>Lexington, MA 02421<br>781-995-2246 | 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 Surgical<br>Instrument with Thermal Effect | |
| Equivalent Device: | Shaser V-MINI (K130015), Radiancy SpaTouch (K020856), Radiance<br>SkinStation (K051671) | |
| Device Description: | Shaser V-MINI RX is an IPL device with a wavelength range of 400-<br>1200 nm. The proposed device removes hair by way of Selective<br>Photothermolysis; the preferential thermal treatment of target tissue<br>without collateral effect of surrounding tissue. The pulsed light heats<br>the hair bulb which disables hair growth. The proposed device is<br>intended for males and females to remove unwanted hair from body<br>sites (legs, arms, chest, underarms, stomach, and bikini line) and from<br>facial sites (chin, cheek, chin, neck, side burns, and above the lips).<br>The V-MINI RX is a battery powered, portable device. Electrical<br>requirement (battery charger) is 115 VAC, 15A, 50-60 Hz, single<br>phase. | |
| Intended Use: | The Shaser V-MINI RX Hair Removal System is intended to provide<br>phototherapeutic light to the body and is generally indicated to treat<br>dermatological conditions. It is also intended for removal of unwanted<br>hair by using a selective photothermal treatment. The Shaser V-MINI<br>RX Hair Removal System is indicated for patient removal of<br>unwanted hair by using a selective photothermal treatment under the<br>direction of a physician, after training by a healthcare professional. It<br>is also indicated for the removal of unwanted body and/or facial hair<br>in adults with Fitzpatrick skin types I - VI. The Shaser V-MINI RX<br>Hair Removal System is also intended for permanent reduction in<br>unwanted hair. Permanent hair reduction is defined as the long-term<br>stable reduction in the number of hairs regrowing when measured at 6,<br>9, and 12 months after the completion of a treatment regimen. | |
| Technical<br>Characteristics: | 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. | |
| Nonclinical<br>Performance Data: | None. | |
| Clinical Performance<br>Data: | 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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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