LUMENA FH HAIR REMOVAL SYSTEM

K140631 · Shaser, Inc. · ONF · May 16, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140631
• Device Name: LUMENA FH HAIR REMOVAL SYSTEM
• Applicant: Shaser, Inc.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: May 16, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Removal of unwanted hair.

Device Story

Lumena FH is an AC-powered, over-the-counter, personal light-based hair removal system. It uses intense pulsed light (IPL) to disable hair growth via selective photothermolysis, heating the hair bulb. The device is operated by the user via a fingerswitch and features a limited-life lamp cartridge. It weighs 1.0 kg and measures 22 x 16 x 78 cm. The user interface consists of LED indicator lights. The device is intended for home use by adults to achieve permanent hair reduction. By providing phototherapeutic light, the device targets hair follicles to inhibit regrowth, offering a non-professional alternative for hair removal.

Clinical Evidence

Clinical evidence consisted of a label comprehension and usability study involving 150 and 123 subjects, respectively, including low-literacy populations. The study evaluated the ability of consumers to understand instructions and safely operate the device in a simulated OTC home-use environment. Results confirmed sufficient label comprehension and safe, appropriate use of the device.

Technological Characteristics

Intense Pulsed Light (IPL) device; wavelength 400-1200nm; fluence settings 6-10 J/cm²; spot size 2cm²; pulse width <200ms; time between flashes <8s. Powered by AC mains (115-230 VAC, 50-60 Hz). Microprocessor-based control. User interface via LED indicator lights. Limited-life lamp cartridge.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV using selective photothermal treatment. Intended for permanent hair reduction, defined as long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment. Over-the-counter use.

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 Hair Removal System (K133201)

Submission Summary (Full Text)

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## K140631 MAY 1 6 7014

### 510(K) Summary

| Submitter: | Shaser, Inc.<br>10 Maguire Road<br>Building 1<br>Lexington, MA 02421 | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact: | Anthony Burns<br>Senior Director of Regulatory Affairs | |
| Date Summary Prepared: | May 13, 2014 | |
| Device Trade Name: | Lumena FH Hair Removal System | |
| Common Name: | Light based hair removal device | |
| Classification Name: | Powered Light Based Non-Laser Surgical Instrument with Thermal<br>Effect. Product Code ONF | |
| Equivalent Device: | Shaser V-MINI 2 Hair Removal System | |
| Device Descripton: | Over-The-Counter, AC Powered, Personal Light-Based Hair Removal<br>System. Emission activation is by fingerswitch. Device includes a<br>limited life lamp cartridge. Overall weight of the device is 1.0 Kg, and<br>the size is 22 x 16 x 78 cm (HxWxD).<br>The Principle of Operation is selective photothermolysis and the<br>Mechanism of Operation is to disable hair growth using light to | |
| | preferentially heat the hair bulb.<br>Electrical Requirement is 115-230 VAC, 50-60 Hz, 1.3A single<br>phase. | |
| Intended Use: | Removal of unwanted hair. | |
| Indication for Use: | Lumena FH 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 Lumena FH is also intended<br>for permanent reduction in unwanted hair. Permanent hair reduction is<br>defined as the long-term stable reduction in the number of hairs<br>regrowing when measured at 6, 9, and 12 months after the completion<br>of a treatment regimen. | |
| Comparison: | The Lumena FH Hair Removal System has the same indication for<br>uses, the same principle of operation, the same pulse energy range and<br>wavelength range as the Shaser V-MINI 2 Hair Removal System. | |
| Exhibit E - (1 of 3) | | |

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| | Proposed Modified Device | Predicate Device 510(k) K133201 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Shaser, Inc. | Shaser, Inc. |
| Trade Name | Lumena FH Hair Removal System | Shaser V-MINI 2 Hair Removal System |
| Indications | Lumena FH is an over the counter device<br>intended to provide phototherapeutic light to<br>the body. It is also intended for removal of<br>unwanted hair by using a selective<br>photothermal treatment. It is also indicated<br>for the removal of unwanted body and/or<br>facial hair in adults with Fitzpatrick skin<br>types I – IV. The Lumena FH is also<br>intended for permanent reduction in<br>unwanted hair. Permanent hair reduction is<br>defined as the long-term stable reduction in<br>the number of hairs regrowing when<br>measured at 6, 9, and 12 months after the<br>completion of a treatment regimen. | Shaser V-MINI 2 is an over the counter<br>device intended to provide phototherapeutic<br>light to the body. It is also intended for<br>removal of unwanted hair by using a<br>selective photothermal treatment. It is also<br>indicated for the removal of unwanted body<br>and/or facial hair in adults with Fitzpatrick<br>skin types I – IV. The Shaser V-MINI 2 is<br>also intended for permanent reduction in<br>unwanted hair. Permanent hair reduction is<br>defined as the long-term stable reduction in<br>the number of hairs regrowing when<br>measured at 6, 9, and 12 months after the<br>completion of a treatment regimen. |
| 'Use<br>Classification' | OTC | OTC |
| Device Type | Intense Pulsed Light | Intense Pulsed Light |
| Wavelength<br>range (nm) | 400nm – 1200nm | 400nm – 1200nm |
| Fluence Settings | 1 = 6 (J/cm²)<br>2 = 7 (J/cm²)<br>3 = 8 (J/cm²)<br>4 = 9 (J/cm²)<br>5 = 10 (J/cm²) | 1 = 6 (J/cm²)<br>2 = 8 (J/cm²)<br>3 = 10 (J/cm²) |
| Spot Size (mm) | 2cm² | 2cm² |
| Pulse Width (ms) | <200 | <200 |
| Time Between<br>Flashes (sec.) | <8 | <8 |
| Source Energy | AC Mains | Battery |
| User Interface | LED indicator lights | LCD display with text and graphics |
| Control<br>Mechanism | Microprocessor-based control | Microprocessor-based control |

Exhibit E – (2 of 3)

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| Nonclinical Performance Data: | Bench testing for performance verification and electrical safety<br>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<br>low literacy subjects. |
| | The results of the two tests confirm sufficient label comprehension<br>and safe and appropriate use of the device. |
| Conclusion: | The results of the nonclinical and clinical performance data<br>conclusively demonstrates that the proposed device is at least as safe<br>and effective as the Lumena FH Hair Removal System and is a safe<br>and effective device for the intended uses. |
| Additional Information: | none |

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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

May 16, 2014

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

Re: K140631

Trade/Device Name: Lumena FH Hair Removal ystem 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 17, 2014 Received: April 18, 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 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 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. 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,

## David Krause -S

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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#### 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 on last page.

510(k) Number (if known) K 14063 I

#### Device Name

Shaser Lumena FH Hair Removal System

#### Indications for Use (Describe)

Lumena FH 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 photothernal treatment. It is also indicated for the removal of unwanted body and/or facial hair in adults with Fitzparick skin types I - IV. The Lumena FH 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 Subpant 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 -2014.05.15 15:18:48 -

FORM FDA 3881 (1/14)

For BSA

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