LOUSEBUSTER

K083206 · Larada Sciences · LJL · Mar 10, 2009 · General Hospital

Device Facts

• Record ID: K083206
• Device Name: LOUSEBUSTER
• Applicant: Larada Sciences
• Product Code: LJL · General Hospital
• Decision Date: Mar 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5960
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Indications for Use

The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.

Device Story

LouseBuster is a portable, prescription-use device for head lice eradication. It consists of a base unit with heating and air movement elements, a flexible delivery hose, and a single-use disposable applicator. The device generates controlled, heated airflow, which the user manually directs to the scalp and hair roots of the patient. The heat kills or removes lice and eggs. The device is operated by trained individuals to deliver treatments. It provides a non-chemical alternative for lice removal, benefiting patients by effectively treating infestations through thermal application.

Clinical Evidence

A clinical trial was conducted comparing the LouseBuster to the predicate device. Results demonstrated that the LouseBuster is safe and effective for its intended use and that individuals completing the training program can deliver safe and effective treatments.

Technological Characteristics

Portable, electrically powered system. Components include base unit with heating/air movement elements, flexible hose, and single-use applicator. Housing is molded, non-metallic. Complies with UL60601-1 and IEC60601-1-2 for electrical/mechanical safety. Biological safety per ISO 10993-1. Operates via controlled, heated airflow.

Indications for Use

Indicated for adults and children 4 years of age and older with head lice infestations to kill or remove lice and lice eggs.

Regulatory Classification

Identification

The lice removal kit is a comb or comb-like device intended to remove and/or kill lice and nits from head and body hair. It may or may not be battery operated.

Predicate Devices

• Robi Comb (K930859)

Submission Summary (Full Text)

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K08320e

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### 510(k) Summary

### Larada Sciences, Inc. LouseBuster™

MAR 1 0 2009

#### ー Preparation Date 28 October 2008

### Submitted By

Randall Block President, COO Larada Sciences, Inc. 825 North 300 West Suite 500 Salt Lake City, UT 84103-1459 Phone [phone] / Fax [phone] [e-mail]

## Contact Person/ Prepared By

Phil Triolo PhD RAC Principal Phil Triolo and Associates LC 148 S. 1200 E. Salt Lake City, UT 84102 Phone [phone] / Fax [phone] [e-mail]

### 2 Device Identification

Trade Name LouseBuster™ Common Name Louse Eradication System Classification Name Lice Removal Kit §880.5960

#### 8 Predicate Device(s)

Robi Comb (cleared under K930859)

#### 4 Device Description

The LouseBuster (LB) is a portable, electrically powered, reusable, prescription-use device that can be used to direct controlled, heated airflow to kill Lice on the hair and scalp of patients with head lice infestations.

The device consists of an applicator, a flexible delivery hose, and a base unit comprising heating and air movement elements with associated safety monitoring and temperature control circuitry. The mechanical and electrical components of the device are protected in a molded, non-metallic housing. A detachable delivery hose provides a pathway for channeling the flowing, heated air created in the base unit to the single-use, disposable applicator. The single-use applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is

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manually positioned by the user to systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.

#### 5 Intended Use

The LouseBuster™ is intended for use to kill or remove lice and lice eggs in the head hair of adults and children 4 years of age and older.

#### Comparisons and Conformance with Standards 6

The device complies with the requirements of UL60601-1 and IEC60601-1-2. Results of additional design verification studies demonstrated that the device met pre-defined acceptance criteria for electrical and mechanical mace. Biological safety risks were found to be acceptable in accordance with ISO 10993-1 and FDA Memo G95-1.

A clinical trial was conducted that demonstrated that the safety and efficacy of the LouseBuster device was equivalent to that of the predicate device. Additionally, clinical study results demonstrated that individuals successfully completing Larada's Training Program deliver safe and effective LouseBuster treatments to individuals infested with head lice.

#### 7 Conclusion

The LouseBuster is substantially equivalent to the predicate Robi Comb and is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem of a caduceus, a symbol of medicine and health, with two snakes entwined around a staff. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring. MD 20993-0002

Larada Sciences, Incorporated C/O Phil Triolo, PhD, RAC Principal Phil Triolo And Associates LC 148 South 1200 East Salt Lake City, Utah 84102

NOV 22 2009

Re: K083206

> Trade/Device Name: Larada Sciences LouseBuster™ Lice Eradication System Regulation Number: 21 CFR 880.5960 Regulation Name: Lice Removal Kit Regulatory Class: I Product Code: LJL Dated: February 27, 2009 Received: March 2, 2009

Dear Dr. Triolo:

This letter corrects our substantially equivalent letter of March 10, 2009.

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 (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.

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.

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### Page 2 - Mr. Triolo

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Snyte y. Michael Oms

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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# Indications for Use

510(k) Number (if known):

Larada Sciences LouseBuster™ Lice Eradication System Device Name:

Indications For Use: The LouseBuster™ is intended for use to kill or remove lice and

lice eggs in the head hair of adults and children 4 years of age and older.

Prescription Use x AND/OR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use ___________ (Part 21 CFR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jol all
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K153206

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