Shaser Skin Beauty Intense Pulsed Light System Family for Acne

K150282 · Shaser, Inc. · ONF · May 27, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150282
• Device Name: Shaser Skin Beauty Intense Pulsed Light System Family for Acne
• Applicant: Shaser, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: May 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body. It is also indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Device Story

Shaser Skin Beauty Intense Pulsed Light (IPL) System is an OTC home-use device for acne treatment. Device inputs include user-activated finger switch triggers; system operates via microprocessor-controlled IPL emission. Principle of operation is photochemical and photothermal; mechanism involves stimulating oxygen production to target P. acnes bacteria and reducing acne-related inflammation. Device features a limited-life treatment head, battery charger, and AC cord. Users operate the device at home; output is phototherapeutic light applied to the skin. Clinical benefit is the reduction of individual acne pimples. Healthcare providers do not operate the device; users follow provided instructions for safe application. Safety and usability were validated through label comprehension and simulated home-use testing.

Clinical Evidence

No clinical efficacy trials were conducted. Evidence consists of a label comprehension and usability study with 84 subjects, including low-literacy individuals, in a simulated home-use environment. Results confirmed that users could understand instructions and operate the device safely and appropriately.

Technological Characteristics

Intense Pulsed Light (IPL) system; wavelength 400-1100nm; max fluence 6.0 J/cm²; spot size 2.0 cm²; pulse width 6s. Powered by AC mains/battery (115 VAC, 15A, 50-60 Hz). Microprocessor-based control; user interface includes LCD display and LED indicators. Limited-life treatment head.

Indications for Use

Indicated for treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

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 Skin Beauty Intense Pulsed Light System Family (K141583)
• CLRS Technology Corp. CLARO (K090744)

Submission Summary (Full Text)

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

May 27, 2015

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

Re: K150282

Trade/Device Name: Shaser Skin Beauty Intense Pulsed Light System Family for Acne 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: April 30, 2015 Received: May 4, 2015

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -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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### Indications for Use

510(k) Number (if known) K150282

Device Name

Shaser Skin Beauty Intense Pulsed Light System Family for Acne

Indications for Use (Describe)

The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

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)

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### 510(K) Summary

| Submitter: | Shaser, Inc.<br>10 Maguire Road<br>Lexington, MA 02421 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Anthony Burns<br>Senior Director of Regulatory Affairs |
| Date Summary Prepared: | January 30, 2015 |
| Device Trade Name: | Shaser Skin Beauty Intense Pulsed Light System Family For Acne |
| Common Name: | Light Based Acne Clearing Device |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument with Thermal<br>Effect<br>79-ONF, 21 CFR 878.4810 |
| Equivalent Devices: | Shaser Skin Beauty Intense Pulsed Light System Family (K141583)<br>CLRS Technology Corp. CLARO (K090744) |
| Device Description: | Shaser Skin Beauty Intense Pulsed Light System Family For Acne is<br>an Over-The-Counter, Light-Based Acne Clearing Device. Emission<br>activation is by finger switch. Device includes a limited life treatment<br>head and battery charger/AC cord. Electrical requirement is 115 VAC,<br>15A, 50-60 Hz, single phase.<br>The Principle of Operation is both photochemical and photothermal.<br>The Mechanism of Action is to stimulate oxygen production which<br>attacks p.acne and to reduce inflammation due to acne. |
| Intended Use: | Treatment of Acne. |
| Indications For Use: | The Shaser Skin Beauty Intense Pulsed Light System Family for Acne<br>is an over-the-counter home use device intended to provide<br>phototherapeutic light to the body. It is also indicated for the<br>treatment of individual acne pimples in persons with mild to moderate<br>inflammatory acne. |
| Comparison: | The Shaser Skin Beauty Intense Pulsed Light System Family For Acne<br>has the same principle of operation and light source, and very similar<br>wavelength range and pulse energy as the predicate devices. The<br>proposed device has the same Intended Use as the CLARO predicate<br>device. |
| 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 home-use environment.<br>• 84 study subjects were tested for label comprehension and for<br>usability. The test populations included low literacy subjects.<br><br>The results of the two tests confirms sufficient label comprehension<br>and safe and appropriate use of the device. |
| Conclusion: | The Shaser Skin Beauty Intense Pulsed Light System Family For Acne<br>is a safe and effective device for the intended use. |
| Additional Information: | None |

Exhibit E (1 of 2)

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### TABLE OF COMPARATIVE FEATURES

| | Proposed 510(k) Device | Predicate Device 510(k)<br>K090744 | Predicate Device<br>510(k) K141583 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shaser, Inc. | CLRS Technology Corp. | Shaser, Inc. |
| Trade Name | Shaser Skin Beauty Intense Pulsed<br>Light System Family for Acne | CLARO | Shaser Skin Beauty Intense Pulsed Light System<br>Family |
| Intended Use | Acne Clearing Device | Acne Clearing Device | Removal of Unwanted Hair |
| Indications | The Shaser Skin Beauty Intense<br>Pulsed Light System Family for<br>Acne is an over-the-counter home<br>use device intended to provide<br>phototherapeutic light to the body,<br>specifically indicated for the<br>treatment of individual acne<br>pimples in persons with mild to<br>moderate inflammatory acne. | The CLARO is indicated for<br>the treatment of individual<br>acne pimples in persons with<br>mild to moderate<br>inflammatory acne. | The Shaser Skin Beauty Intense Pulsed Light System<br>Family is an over-the-counter home use device<br>intended to provide phototherapeutic light to the<br>body. It is also intended for removal of unwanted hair<br>by using a selective photothermal treatment. It is also<br>indicated for the removal of unwanted body and/or<br>facial hair in adults with Fitzpatrick skin types I – IV.<br>The Shaser Skin Beauty Intense Pulsed Light System<br>Family is also intended for permanent reduction in<br>unwanted hair. Permanent hair reduction is defined as<br>the long-term stable reduction in the number of hairs<br>regrowing when measured at 6, 9, and 12 months<br>after the completion of a treatment regimen. |
| 'Use'<br>Classification | OTC | OTC | OTC |
| Device<br>Classification | Class II | Class II | Class II |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light |
| | Proposed 510(k) Device | Predicate Device<br>510(k) K090744 | Predicate Device<br>510(k) K141583 |
| Wavelength (nm) | 400 - 1100nm | 400 - 1100nm | 400 - 1200nm |
| Max. Fluence<br>(J/cm²) | 6.0 | 6.0 | 10 |
| Spot Size (cm²) | 2.0 | 1.0 | 2.0 |
| Pulse Width (s) | 6 | 6 | <.2 |
| Source Energy | AC Mains/Battery | Battery | AC Mains/Battery |
| User Interface | LCD display with text and graphics<br>/LED Indicator lights | LED Indicator lights | LCD display with text and graphics /LED<br>Indicator lights |
| Control<br>Mechanism | Microprocessor based | Non-Microprocessor based | Microprocessor based |
| Treatment<br>Regime | 1 application = 6 seconds | 1 application = 6 seconds | 1 application < .2 seconds |
| | 1 Treatment = 2 applications | 1 Treatment = 2 applications | 1 Treatment = 1 application |
| | No more treatments than:<br>1 every 8 hours<br>4 in a seven day period. | No more treatments than:<br>1 every 8 hours<br>4 in a seven day period. | No more treatments than:<br>1 every two weeks. |

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## TABLE OF COMPARATIVE FEATURES

Exhibit C (2 of 2)