(72 days)
Not Found
No
The device description focuses on mechanical and electrical components for heated airflow and temperature control, with no mention of AI or ML technologies.
Yes
The device is intended to treat a condition (lice infestation) by killing lice and their eggs, which is a therapeutic action.
No
No
The device description clearly outlines physical hardware components including an applicator, hose, base unit with heating and air movement elements, and associated circuitry, indicating it is not a software-only device.
Based on the provided information, the LouseBuster™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- LouseBuster's Function: The LouseBuster™ directly applies heated air to the head hair and scalp to kill or remove lice and lice eggs. It does not involve the collection or analysis of specimens from the body.
- Intended Use: The intended use is to treat a condition (head lice infestation) by physically eliminating the causative agents, not to diagnose or provide information about a disease through laboratory analysis.
Therefore, the LouseBuster™ falls under the category of a therapeutic or treatment device, not an IVD.
N/A
Intended Use / 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.
Product codes
LJL
Device Description
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 systematically direct heated air to kill or remove lice present in the scalp and hair roots of an infested individual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head hair, scalp
Indicated Patient Age Range
adults and children 4 years of age and older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5960 Lice removal kit.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
| Larada Sciences,
Inc. | Premarket Notification
LouseBuster™ | Oct. 02, 2009
Page 18 of 40 |
| -------------------------- | ---------------------------------------- | -------------------------------- |
|---|
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 (801) 533 5423 / Fax 801 355 5423 randall@laradasciences.com
Contact Person/ Prepared By
Phil Triolo PhD RAC Principal Phil Triolo and Associates LC 148 S. 1200 E. Salt Lake City, UT 84102 Phone (801) 699 9846 / Fax 801 328 2399 philt@philt.com
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
1
| 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.
2
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.
3
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 (800) 638-2041 or (240) 276-3150 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
4
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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