SHASER V-MINI 2 HAIR REMOVAL SYSTEM

K133201 · Shaser, Inc. · ONF · Feb 12, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133201
• Device Name: SHASER V-MINI 2 HAIR REMOVAL SYSTEM
• Applicant: Shaser, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Feb 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Removal of unwanted hair.

Device Story

Shaser V-MINI 2 is an OTC, cordless, rechargeable light-based hair removal system. Device utilizes selective photothermal treatment to target hair follicles. Operated by user via finger switch. Includes limited-life treatment head and battery charger. Intended for home use by adults to achieve permanent hair reduction. Output is phototherapeutic light; healthcare providers do not operate device; users follow provided instructions for safe application. Benefit is long-term stable reduction of unwanted hair.

Clinical Evidence

No clinical efficacy trials. Evidence consists of label comprehension (n=150) and usability testing (n=123) in simulated OTC home-use environment, including low-literacy subjects. Results confirmed sufficient comprehension and safe, appropriate device use.

Technological Characteristics

Cordless, rechargeable light-based hair removal device. Dimensions: 2.1 x 0.6 x 0.8 cm. Electrical requirement: 115 VAC, 15A, 50-60 Hz. Includes limited-life treatment head. Principle: selective photothermal treatment.

Indications for Use

Indicated for phototherapeutic light delivery and removal of unwanted body/facial hair in adults with Fitzpatrick skin types I-IV via selective photothermal treatment. Intended for permanent hair reduction, defined as long-term stable reduction in regrowing hairs measured at 6, 9, and 12 months post-treatment.

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 Hair Removal System (K130015)
• Shaser HRS2 Rx Hair Removal System (k132266)

Submission Summary (Full Text)

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### 510(K) Summary

## FEB 12 2014

| Submitter: | Shaser, Inc.<br>10 Maguire Road<br>Lexington. MA 02421 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Anthony Burns<br>Senior 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 Thermal<br>Effect<br>79-ONF, 21 CFR 878.4810 |
| Equivalent Devices: | Shaser V-MINI Hair Removal System (K130015) and Shaser HRS2<br>Rx Hair Removal System (k132266) |
| Device Description: | Shaser V-MINI 2 is an Over-The-Counter, Cordless, Rechargeable<br>Light-Based Hair Removal System. Emission activation is by finger<br>switch. Device includes a limited life treatment head and battery<br>charger. Overall weight size is 2.1 x 0.6 x 0.8 cm. Charger electrical<br>requirement 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 provide<br>phototherapeutic light to the body. It is also intended for removal of<br>unwanted hair by using a selective photothermal treatment. It is also<br>indicated for the removal of unwanted body and/or facial hair in adults<br>with Fitzpatrick skin types I - IV. The Shaser V-MINI 2 is also<br>intended for permanent reduction in unwanted hair. Permanent hair<br>reduction is defined as the long-term stable reduction in the number of<br>hairs regrowing when measured at 6, 9, and 12 months after the<br>completion of a treatment regimen. |
| Comparison: | The Shaser V-MINI 2 has the same Intended Use, the same principle<br>of operation, the same pulse energy range, and very similar wavelength<br>range 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 to<br>understand the instructions for use and to evaluate their ability to use<br>the device safely in a simulated OTC home-use environment. |
| | 150 study subjects were tested for label comprehension and 123<br>study 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 [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,

# 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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#### Indications for Use

510(k) Number (if known): K133201

Device Name: Shaser V-MINI 2

Indications For Use:

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.

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)