LX-100 Hair Growth Stimulation System

K142824 · Hairlabs International, Inc. · OAP · Apr 14, 2015 · Physical Medicine

Device Facts

• Record ID: K142824
• Device Name: LX-100 Hair Growth Stimulation System
• Applicant: Hairlabs International, Inc.
• Product Code: OAP · Physical Medicine
• Decision Date: Apr 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.

Device Story

LX-100 is a stationary, spherical laser helmet for hair growth stimulation; uses 90 lasers at 650nm wavelength to provide biostimulation to the scalp. Operated by a physician or trained technician in a clinical setting; requires prescription. Device features computer-controlled treatment protocols, including adjustable time and dosage settings. Safety features include key lock, warning labels, on-screen prompts for safety glasses, and beam interruption sensors that disable lasers if the patient moves or tilts their head. Output is continuous wave laser light. Benefits include non-invasive promotion of hair growth for specified alopecia patients.

Clinical Evidence

Bench testing only. The device met all design verification and validation criteria. Equivalence is based on technological characteristics (wavelength, power, dosage) and comparison to previously cleared devices (K091496, K122950) with established clinical efficacy for the same indications.

Technological Characteristics

Stationary laser helmet; 90 lasers; 650nm (±1%) wavelength; ≤4.5mW per diode; 3V DC power; injection-molded polycarbonate/polystyrene and fiberglass construction; two-part epoxy paint. Features computer-controlled treatment timing and dosage. Safety: key lock, beam interruption sensors, head proximity circuitry. No sterilization required.

Indications for Use

Indicated for females with androgenetic alopecia, Ludwig and Savin scale I-II, and Fitzpatrick skin types I-IV, to promote hair growth as an adjunctive treatment.

Regulatory Classification

Identification

An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.

Special Controls

*Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• MEP-90 Hair Growth Stimulation System (K091496)
• Laser Helmet LH80 PRO (K122950)

Reference Devices

• Clinical Laser G (K132646)

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

April 14, 2015

HairLabs International Incorporated Mr. James Britt President 742 Harpeth Knoll Road Nashville, Tennessee 37221

Re: K142824

Trade Name: LX-100 Hair Growth Stimulation System Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP, NHN Dated: September 25, 2014 Received: September 30, 2014

Dear Mr. Britt:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

# 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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# Concurrence & Template History Page [THIS PAGE IS INCLUDED IN IMAGE COPY ONLY]

Full Submission Number:

For Office of Compliance Contact Information:

http://insideportlets.fda.gov:9010/portal/page?_pageid=197,415881&_dad=portal&_schema=PORTAL&org=318

For Office of Surveillance and Biometrics Contact Information:

http://insideportlets.fda.gov:9010/portal/page? pageid=197,415881& dad=portal& schema=PORTAL&org=423

| Digital Signature Concurrence Table | |
|-------------------------------------|--|
| Reviewer Sign-Off | |
| Branch Chief Sign-Off | |
| Division Sign-Off | |

Template Name: K1(A) – SE after 1996

Template History:

| Date of Update | By | Description of Update |
|----------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7/27/09 | Brandi Stuart | Added Updates to Boiler Table |
| 8/7/09 | Brandi Stuart | Updated HFZ Table |
| 1/11/10 | Diane Garcia | Liability/Warranty sentence added at bottom of 1st page |
| 10/4/11 | M. McCabe Janicki | Removed IFU sheet and placed in Forms |
| 9/25/12 | Edwena Jones | Added digital signature format |
| 12/12/12 | M. McCabe Janicki | Added an extra line between letter signature block and the word<br>"Enclosure". Also, added a missing digit in 4-digit extension on<br>letterhead zip code: "002" should be "0002". |
| 4/2/2013 | M. McCabe Janicki | Edited sentence that starts "If you desire specific advice for your<br>device on our labeling regulation (21 CFR Part 801)." Replaced<br>broken Compliance link with general link to DSMICA. |
| 4/12/2013 | Margaret McCabe<br>Janicki | Fixed a typo: Paragraph 1, final sentence, "We remind you,<br>however; that device labeling must be truthful." Replaced<br>incorrect semicolon with a comma. |

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## Indications for Use

510(k) Number (if known) K142824

### Device Name

LX-100 Hair Growth Stimulation System

Indications for Use (Describe)

The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for:

Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.

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

2 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)

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# HairLabs International Inc.

# 510(k) Summary

(as required per 21 CFR: §807.92)

## LX-100 Hair Growth Stimulation System

- l. Applicant: Hairlabs International, Incorporated 742 Harpeth Knoll Road Nashville, TN 37221
Phone: [phone]

- II. Contact Name: James Britt, President [e-mail]
### III. Device Name:

| Proprietary Name | LX-100 Hair Growth Stimulation System |
|---------------------|---------------------------------------|
| Common/Usual Name | Light Therapy Hair System |
| Classification Name | Infrared Lamp per 21CFR 890.5500 |

Product Code(s)............................................................... OAP

### IV. Predicate Devices And Comparison

| Predicate Device<br>Comparative Item | Hairlabs<br>International<br>LX-100 | Midwest RF<br>MEP-90 | Theradome Inc.<br>LH80 Pro |
|-----------------------------------------|---------------------------------------------|---------------------------------------------|----------------------------|
| 501(k) Number | K142824 | K091496 | K122950 |
| Device Name | LX-100 Hair<br>Growth Stimulation<br>System | MEP-90 Hair<br>Growth Stimulation<br>System | Laser Helmet LH80<br>PRO |
| Manufacture | Hairlabs<br>International, Inc. | Midwest RF, LLC | Theradome, Inc. |
| Establishment<br>Registration<br>Number | N/A | 2134565 | Unknown |
| Device<br>Regulation<br>Description | Infrared Lamp | Infrared Lamp | Infrared Lamp |
| Device<br>Regulation<br>Number | 21CFR; §890.5500 | 21CFR; §890.5500 | 21CFR; §890.5500 |
| Device | A device that emits | A device that emits | A device that emits |

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| Regulation<br>Identification/<br>Classification | energy at infrared<br>frequencies<br>(approximately 700<br>nanometers to<br>50,000 nanometers<br>to provide topical<br>heating. | energy at infrared<br>frequencies<br>(approximately 700<br>nanometers to<br>50,000 nanometers<br>to provide topical<br>heating. | energy at infrared<br>frequencies<br>(approximately 700<br>nanometers to<br>50,000 nanometers<br>to provide topical<br>heating. |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Physical State | Light emitting<br>stimulator | Light emitting<br>stimulator | Light emitting<br>stimulator |
| Product<br>Nomenclature | Lamp, infrared | Lamp, infrared | Lamp, infrared |
| Product Code | OAP | OAP | OAP |
| Device Class | Class 2 | Class 2 | Class 2 |
| 21CFR Part 1010<br>Laser<br>Classification/<br>Compliance | Illa; IIIr<br>Full Compliance | Illa; IIIr<br>Full Compliance | Illa; IIIr |
| FDA Device Risk<br>Classification | Non-significant<br>(NSR) | Non-significant<br>(NSR) | Non-significant<br>(NSR) |
| Wavelength (λ) | 650nm (+/-1%)<br>644nm to 656nm<br>Measured | 650nm (+/-1%)<br>644nm to 656nm<br>Measured | 678nm center<br>wavelength<br>Published |
| Output Per Diode<br>in mw | ≤4.5mW Measured | ≤4.5mW Measured | ≤5mW<br>Unpublished |
| Treatment Area in<br>cm2 | 1065.10 cm2<br>Mathematically<br>derived | 990.80 cm2<br>Mathematically<br>derived | 990.80 cm2<br>Mathematically<br>derived |
| Total Output for<br>Treatment Area,<br>Dosage mW/cm2 | .3802 mW/cm2<br>Mathematically<br>Derived | .3724 mW/cm2<br>Mathematically<br>Derived | .4037 mW/cm2<br>Mathematically<br>Derived |
| Recommended<br>Treatment<br>Regimen | 2 - 20 Minute<br>Treatments Per<br>Week, On Non-<br>consecutive Days<br>for 26 Weeks for a<br>Total of 52<br>Treatments | 2 - 20 Minute<br>Treatments Per<br>Week, On Non-<br>consecutive Days<br>for 18 Weeks for a<br>Total of 36<br>Treatments | 2 - 20 Minute<br>Treatments Per<br>Week, On Non-<br>consecutive Days<br>for 26 Weeks for a<br>Total of 52<br>Treatments |
| Fluence, 20<br>Minute Treatment<br>J/cm2 | .45629 J/cm2<br>Mathematically<br>derived | .44691 J/cm2<br>Mathematically<br>derived | .48446 J/cm2<br>Mathematically<br>Derived |
| Number of Lasers | 90 | 82 | 80 |
| Laser Pulse Rate | Continuous | Continuous | Continuous |
| Laser Pulse<br>Duration | Continuous | Continuous | Continuous |
| Power | 3Volts DC;<br>110 Volts AC<br>converted to<br>24 Volts DC | 3 Volts DC:<br>110 Volts AC<br>converted to<br>24 Volts DC | Unknown<br>proprietary |

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| Aiming Beam | No lens; diffused beam, fixed coverage | No lens; diffused beam, fixed coverage | No lens, diffused beam, fixed coverage |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Laser Beam Scattering Outside Aperture | None - Fixed angulation and required beam interruption prevent beam scattering outside of Helmet assembly | None - Fixed angulation and required beam interruption prevent beam scattering outside of Helmet assembly | None when patient is in helmet. |
| Output Mode | Direct Light | Direct Light | Direct Light |
| Sterilization | Basic cleaning, Instructions provided; No sterilization claimed, called for or possible | Basic cleaning, Instructions provided; No sterilization claimed, called for or possible | No sterilization claimed or called for in published materials |
| Device Type | Free standing, movable laser helmut, spherical laser helmet | Free standing, movable laser helmet, spherical laser helmet | Portable helmet only, sits on patients head, spherical laser helmet |
| Accessories | None; all items described are necessary for basic operation including safety keys for key lock, 10' medical grade power cord, operation manual and 2 pair laser safety glasses | None; all items described are necessary for basic operation including mouse, keyboard, monitor, safety keys for key lock, 10' medical grade power cord, operation manual and 2 pair laser safety glasses | None; all items described are necessary for basic operation including wall charger |

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| Materials | Injection molded<br>and painted<br>polycarbonate and<br>polystyrene,<br>Molded and<br>painted fiberglass.<br>All paint is two part<br>epoxy based. | Injection molded<br>and painted<br>polycarbonate and<br>polystyrene,<br>Molded and<br>painted fiberglass.<br>All paint is two part<br>epoxy based. | Unkown and would<br>be proprietary<br>information under<br>18U.S.C.§1832-<br>Assumed no<br>issues due to<br>issuance of 510(k) | Unknown and<br>would be<br>proprietary<br>information under<br>18U.S.C§1832-<br>Assumed no<br>issues due to<br>issuance of 510(k) |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | There are no new<br>materials in use on<br>this device that are<br>not in routine use<br>on other devices.<br>The<br>biocompatibility is<br>comparable to any<br>of the legally<br>marketed devices<br>listed as follows:<br>Midwest RF<br>K091496<br>Model MEP-90<br>Sunetics<br>International<br>K132646<br>Model Clinical<br>Laser G<br>Theradome, Inc<br>K122950<br>Model LH80 PRO | Assumed no<br>issues due to<br>issuance of 510(k) | Assumed no<br>issues due to<br>issuance of 510(k) | Assumed no<br>issues due to<br>issuance of 510(k) |
| Indications of Use | LX-100 is for<br>adjunctive use for<br>the treatment of<br>androgenic<br>(androgenetic)<br>alopecia in females<br>and is indicated to<br>promote hair<br>growth of females<br>with androgenic<br>(androgenetic)<br>alopecia who have<br>Ludwig and Savin<br>Hair Loss Scale<br>classifications of I<br>to II and who have<br>been determined to<br>have a Fitzpatrick<br>Skin Typing of I to<br>IV | MEP-90 is for<br>adjunctive use for<br>the treatment of<br>androgenic<br>(androgenetic)<br>alopecia in females<br>and is indicated to<br>promote hair<br>growth of females<br>with androgenic<br>(androgenetic)<br>alopecia who have<br>Ludwig and Savin<br>Hair Loss Scale<br>classifications of I<br>to II and who have<br>been determined to<br>have a Fitzpatrick<br>Skin Typing of I to<br>IV | Laser Helmet LH80<br>PRO is an over the<br>counter (OTC)<br>device indicated to<br>treat androgenic<br>alopecia, to<br>promote hair<br>growth in females<br>with female pattern<br>hair loss (FPHL) on<br>the Ludwig and<br>Savin Hair Loss<br>Scale I-II,<br>Fitzpatrick Skin-<br>Types I to IV | |
| Indications of Use<br>Source | Prescription | Prescription | Over The Counter | |
| Indications of Use<br>Sale and Usage<br>Restrictions | Direction of<br>Licensed Physician<br>only | Direction of<br>Licensed Physician<br>only | Over The Counter | |
| Indications of Use<br>Installation | Certified on site | Certified on site | Drop shipped to<br>user | |
| Indications of Use<br>Operator and<br>User Training /<br>Education | Factory and/or on<br>site training at<br>installation;<br>Internet access for<br>Operations Manual | Factory and/or on<br>site training (User<br>option) of<br>approximately 6-8<br>hours at<br>installation;<br>Internet access for<br>operational<br>updates; Operation<br>Manual; Continuing<br>education program<br>TBD | Operation manual | |
| Indications of Use<br>Operation Control<br>and Length of<br>Treatment | Default settings for<br>recommended<br>treatment protocol;<br>Operator resets of<br>time and dosage<br>which is controlled<br>by computer | Default settings for<br>recommended<br>treatment protocol;<br>Operator resets of<br>time and dosage<br>which is controlled<br>by computer | Single button<br>control, button<br>push starts one 20<br>minute cycle, unit<br>turns off when<br>cycle ends | |
| Indications of Use<br>Safety In<br>Operation | Warning labels on<br>device; key lock<br>with on screen<br>warning; default<br>treatment settings;<br>fixed maximum<br>power output<br>regardless of<br>settings; constant<br>thru beam interrupt<br>by patient required<br>for laser operation;<br>warning on screen<br>to insure operator<br>and patient are<br>wearing safty<br>glasses before<br>lasers will operate;<br>no beam scatter<br>outside of helmet<br>assembly; tilting of<br>head no ≥3/8"<br>interrupt | Warning labels on<br>device; key lock<br>with on screen<br>warning; default<br>treatment settings;<br>fixed maximum<br>power output<br>regardless of<br>settings; constant<br>thru beam interrupt<br>by patient required<br>for laser operation;<br>warning on screen<br>to insure operator<br>and patient are<br>wearing safty<br>glasses before<br>lasers will operate;<br>no beam scatter<br>outside of helmet<br>assembly; tilting of<br>head no ≥3/8"<br>interrupt; head<br>proximity safety<br>circuitry | Unknown -<br>proprietary | |

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### V. Indications For Use

The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for:

Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV

### VI. Technological Characteristics

The LX-100 is a stationary low-level laser device that promotes hair growth and provides adjunctive treatment for androgenic (androgenetic) alopecia in females. The device provides automated and timed equal distribution of laser light to 100% of the scalp.

The LX-100 operation is controlled by an operating system that affords the user maximum flexibility for individual treatments. The device applies a measured very high tolerance (≤+1%) wavelength (λ) to the scalp stimulating hair growth by the proven concept of biostimulation.

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## Performance Data and Clinical Efficacy

The LX-100 Hair Growth Stimulation System met all of the specified acceptance criteria of the design verification and validation testing performed under design control and is found to be substantially equivalent to the currently marketed and approved predicate devices.

#### VII. Conclusion

The LX-100 is substantially equivalent to other pulsed therapeutic light therapy svstems currently in commercial distribution. The LX-100 has the same intended use and technological and safety characteristics to the predicate devices approved for commercial distribution under 510(k) number K091496, and K122950.

It equals the clinically accepted therapeutic results standards of FDA 510(k) K091496, and K122950 previously approved light therapy systems.

The technological equivalence to the predicate devices is substantiated by the wavelength, power output and dosage generated by the LX-100. The LX-100 provides expanded treatment benefits and regimens for clinical presentations already approved by the Food and Drug Administration for the predicate device.

The LX-100 is as safe and effective as a combination of the predicate devices listed and numerous others. It has the same intended use of affecting hair growth as the hair growth predicate device (K091496, and K122950). In addition, the LX-100 has the same general indications, i.e., treating androgenic alopecia, and the same specific indication of promoting hair growth as the predicate device.

The LX-100 also has many of the same or similar technological characteristics as a combination of its predicate devices. These include multiple lasers and visible laser wavelength.