LOUSEBUSTER

K093144 · Larada Sciences · LJL · Dec 16, 2009 · General Hospital

Device Facts

• Record ID: K093144
• Device Name: LOUSEBUSTER
• Applicant: Larada Sciences
• Product Code: LJL · General Hospital
• Decision Date: Dec 16, 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, electrically powered 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 user manually positions the applicator to direct controlled, heated airflow onto the scalp and hair roots. The heat kills lice and eggs. The device is intended for over-the-counter use by adults or caregivers. It provides a non-chemical alternative for lice removal.

Clinical Evidence

No new clinical data provided; substantial equivalence is based on the device being identical to the previously cleared predicate device.

Technological Characteristics

Portable, electrically powered, reusable base unit with heating and air movement elements. Includes flexible delivery hose and single-use disposable applicator. Molded, non-metallic housing. Safety monitoring and temperature control circuitry included.

Indications for Use

Indicated for killing or removing lice and lice eggs in the head hair of adults and children 4 years of age and older.

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

• LouseBuster (K083206)

Submission Summary (Full Text)

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K093144

| Larada Sciences,<br>Inc. | Premarket Notification<br>LouseBuster™ | Oct. 02, 2009<br>Page 18 of 40 |
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## 5. 510((k) Summary

5.1 Preparation Date 02 October 2009

- 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]

## 5.2 Device Identification

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

## 5.3 Predicate Device(s)

LouseBuster (K083206)

## 5.5 Device Description

.. .. .....

,·· ·

ﻪ ﻧ

The LouseBuster (LB) is a portable, electrically powered, reusable, 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 singleuse applicator is attached to the hose by the user before initiating LB treatment. During treatments, the applicator is manually positioned by the user to

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| Larada Sciences, | Premarket Notification | Oct. 02, 2009 |
|------------------|------------------------|---------------|
| Inc. | LouseBuster™ | Page 19 of 40 |

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

### 5.6 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 5.7

No design changes have been made to the device. From design and manufacturing standpoints, the subject LouseBuster device is identical to the cleared LouseBuster device.

#### 5.8 Conclusion

The LouseBuster intended for non-prescription use is substantially equivalent to the predicate LouseBuster intended for prescription use, and is safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

DEC 1 6 2009

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

Re: K093144

> 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: October 2, 2009 Received: October 5, 2009

Dear Dr. Triolo:

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.

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- Dr. 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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html

Sincerely yours,

Susan Runes

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Device Name: -

Larada Sciences LouseBuster™ Lice Eradication System
The LouseBuster

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

lice and
made 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 AND/OR ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Over-The-Counter Use _ X ___ (Part 21

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles E
(Divisio

(Division Sign-Off) (Pression Off)
Division of Anesthesiology, General Hospital The Store of Anesthesiology, General Devices

510(k) Number: K093160

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