KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT

K991958 · Kiel Laboratories, Inc. · LJL · Aug 13, 1999 · General Hospital

Device Facts

• Record ID: K991958
• Device Name: KLOUT SHAMPOO AND LICE COMBING PRETREATMENT KIT
• Applicant: Kiel Laboratories, Inc.
• Product Code: LJL · General Hospital
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5960
• Device Class: Class 1

Indications for Use

the removal of head lice and their eggs (nits) from hair

Device Story

KLOUT™ kit consists of stainless steel lice comb and pretreatment shampoo. Comb features teeth with 0.3 mm (300 micron) spacing to mechanically remove nits and lice from hair. Shampoo facilitates removal process by allowing rinsing and combing of nits; contains no pesticides. Intended for home use by consumers. Device aids in physical removal of lice and nits; does not provide ovicidal or pediculicidal chemical action.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel comb with 0.3 mm (300 micron) tooth spacing. Non-pesticidal pretreatment shampoo. Manual operation. No electronic components, software, or energy sources.

Indications for Use

Indicated for the removal of head lice and their eggs (nits) from hair.

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

• CLEAR™ LICE EGG REMOVER SYSTEM (K981147)
• LICEMEISTER™ COMB (K981250)

Submission Summary (Full Text)

{0}------------------------------------------------

AUG 1 3 900

K991958

## 510 (k) NOTIFICATION KIEL LABORATORIES, INC. SUMMARY

KIEL LABORATORIES, INC. 2225 CENTENNIAL DRIVE GAINESVILLE, GA. 30504

CONTACT: TANYJA PORCHÁ PHONE: [phone] FAX: [phone]

### DATE PREPARED: 6/04/99

LICE COMB AND PRETREATMENT KIT DEVICE NAME: PROPRIETARY NAME: CLASS: 1 PANEL: PRODUCT CODE: LJL CLASSIFICATION NAME: PREDICATE DEVICE:

KLOUT™ LICE COMB and PRETREATMENT SHAMPOO GENERAL HOSPITAL DETECTORS AND REMOVERS, LICE (including combs) CLEAR™ LICE EGG REMOVER SYSTEM - K981147 LICEMEISTER™ COMB - K981250

### DESCRIPTION AND INTENDED USE:

The kit consists of two components, the combing pretreatment shampoo. The comb is stainless steel with the teeth set to 0.3 mm (300 micron) spacing and capable of removing nits which are greater than 0.3 mm when attached to the hair. The second element is a shampoo that contains no pesticides but does facilitate lice removal and allows for rinsing and combing the nits out of the hair.

intended use/indications: the removal of head lice and their eggs (nits) from hair

#### BASIS FOR COMPARISON:

| basis for comparison | KLOUT™ kit | CLEAR® system |
|------------------------|------------|---------------|
| comb included | yes | yes |
| removal of nits | yes | yes |
| ovicidal | no | no |
| removal of lice | yes | no |
| pediculicidal | no | no |
| where used | home | home |
| active ingredient | none | none |
| anatomical site of use | hair/head | hair/head |

section 5.wpd

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three heads in profile, suggesting a sense of community and care. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 1999

Ms. Tanya Porcha Director of Requlatory Affairs Kiel Laboratories, Incorporated 2225 Centennial Drive Gainesville. Georgia 30504

Re : K991958 Klout Shampoo and Lice Combing Pretreatment Kit · Trade Name: Regulatory Class: I Product Code: LJL June 09, 1999 Dated: Received: July 30, 1999

Dear Ms. Porcha

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{2}------------------------------------------------

Page 2 - Mr. Porcha

This letter will allow you to begin marketing your device as Info iceeer wire as ( ) premarket notification. The FDA finding described in your sialence of your device to a legally marketed or babbtanded on a classification for your device and thus, permits your device to proceed to the market. enab/ Desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro regaractic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and (Jul, Joing of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small under cho not maj at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html" .

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K991958

# 510 (k) NOTIFICATION KIEL LABORATORIES, INC.

intended use/indications: the removal of head lice and their eggs (nits) from hair

Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use.

Over the Moon...

Seulen Briler

Page 1 of 1

Sign-Off) ton control, (Division Sig of Dental, Infection Control Tospital Devices

section 1.wpd