SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY

K141583 · Shaser, Inc. · ONF · Jul 22, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141583
• Device Name: SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
• Applicant: Shaser, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Jul 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device 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 with Fitzpatrick skin types 1-IV. The Shaser Skin Beauty Intense Pulsed Light System Family 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

Over-the-counter, light-based hair removal system; available in AC mains-powered and battery-powered versions. Principle of operation: selective photothermolysis; mechanism: light energy preferentially heats hair bulb to disable growth. Device includes limited-life treatment head; activation via finger switch. Used in home environment by consumers. Output: pulsed light energy. Benefit: permanent reduction of unwanted hair, defined as long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment.

Clinical Evidence

Clinical data focused on label comprehension and usability in a simulated OTC home-use environment. Study included 150 subjects for label comprehension and 123 subjects for usability, including low-literacy populations. Results confirmed sufficient comprehension and safe, appropriate device use by consumers.

Technological Characteristics

Powered light-based non-laser surgical instrument. Principle: selective photothermolysis. Energy source: AC mains (115 VAC, 15A, 50-60 Hz) or battery. Form factor: handheld device with limited-life treatment head. Operation: finger switch activation.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-IV.

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 2 (K133201)
• Shaser Lumena FH (K140631)

Submission Summary (Full Text)

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# 510(K) Summary

# KI41583 JUL 2 2 2014

## Submitter: Shaser, Inc. 10 Maguire Road Lexington, MA 02421 Contact: Anthony Burns Senior Director of Regulatory Affairs Date Summary Prepared: June 12, 2014 Shaser Skin Beauty Intense Pulsed Light System Family Device Trade Name: Light Based Hair Removal Device Common Name: Powered Light Based Non-Laser Surgical Instrument with Thermal Classification Name: Effect 79-ONF, 21 CFR 878.4810 Equivalent Devices: Shaser V-MINI 2 (K133201) Shaser Lumena FH (K140631) Device Description: Shaser Hair Skin Beauty Intense Pulsed Light System Family devices are Over-The-Counter, Light-Based Hair Removal Systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Operation is to disable hair growth using light to preferentially heat the hair bulb. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. Removal of unwanted hair. Intended Use: The Shaser Skin Beauty Intense Pulsed Light System Family is an over-Indications For Use: the-counter device 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 Skin Beauty Intense Pulsed Light System Family 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. The Shaser Skin Beauty Intense Pulsed Light System Family devices Comparison: (the Shaser V-MINI 2 and the Shaser Lumena FH) have identical Indications for Use, identical Fundamental Science and identical

Exhibit E (1 of 2)

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| | materials. Fundamental Science and identical materials. The performance specifications of the two devices are identical and the two devices are manufactured by the same manufacturer. The two devices have the same basic design and performance characteristics related to device safety and effectiveness, identical intended use and function, and the same device classification and product code. The Shaser Skin Beauty Intense Pulsed Light System Family has the same principle of operation, the same pulse energy range, and same wavelength range. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical Performance Data: | Bench testing for performance verification and electrical safety testing. |
| Clinical Performance Data: | Label comprehension and usability test of consumers' ability to understand the instructions for use and to evaluate their ability to use the device safely in a simulated OTC home-use environment. |
| | <ul><li>150 study subjects were tested for label comprehension and 123 study subjects tested for usability. Both test populations included low literacy subjects. </li></ul> |
| | The results of the two tests confirm sufficient label comprehension and safe and appropriate use of the device. |
| Conclusion: | The results of the nonclinical and clinical performance data conclusively demonstrates that the proposed device is at least as safe and effective as the V-MINI 2 and the Lumena FH and is a safe and effective device for the intended uses. |
| Additional Information: | None |

、

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Public Health Service

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

July 22, 2014

Shaser Incorporated Mr. Anthony Burns Senior Director of Regulatory Affairs Suite 120, Building 1 10 Maguire Road Lexington, MA 02421

Re: K141583

Trade/Device Name: Shaser Skin Beauty Intense Pulsed Light System Family 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, GEX Dated: June 26, 2014 Received: June 27, 2014

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 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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K141583

#### Device Name

Shaser Skin Beauty Intense Pulsed Light System Family

Indications for Use (Describe)

The Shaser Skin Beauty Intense Pulsed Light System Family is an over-the-counter device 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 with Fitzpatrick skin types 1-IV. The Shaser Skin Beauty Intense Pulsed Light System Family 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.

### Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Neil R Ogden -S 2014.07.21 15:27:47 -04'00'

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