WET LIGHT PERSONAL MOISTURIZER

K013086 · Trigg Laboratories, Inc. · HIS · Dec 13, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K013086
• Device Name: WET LIGHT PERSONAL MOISTURIZER
• Applicant: Trigg Laboratories, Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: Dec 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

WET® Light Personal Moisturizer is intended for vaginal application to enhance personal moisture in the vaginal area to enhance sexual pleasure. It is also used for lubricating sexual devices and for easy insertion of rectal thermometers, tampons, douche and enema nozzles.

Device Story

WET® Light Personal Moisturizer is a topical lubricant applied to the vaginal area or sexual devices. It functions as a personal moisturizer to enhance sexual pleasure and as a lubricant to facilitate the insertion of medical devices such as rectal thermometers, tampons, and douche or enema nozzles. It is intended for over-the-counter use by consumers.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for individuals requiring personal lubrication for vaginal moisture enhancement, sexual pleasure, and as a lubricant for sexual devices, rectal thermometers, tampons, douche, and enema nozzles. Over-the-counter use.

Regulatory Classification

Identification

A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.

Special Controls

*Classification.* (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 3 2001

Trigg Laboratories, Inc. % Mr. W. Patrick Noonan Regulatory Counsel W. Patrick Noonan Warner Center Plaza, Suite 840 21800 Oxnard Street WOODLAND HILLS CA 91367 Re: K013086

K013060
Trade/Device Name: WET® Light Personal Moisturizer Regulation Number: 21 CFR 880.6375 Regulation Name: Patient lubricant Regulatory Class: II Product Code: 85 MMS Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: September 12, 2001 Received: September 14, 2001

Dear Mr. Noonan:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(th) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Cherosule) to regally manation program date of the Medical Device American Co commerce prior to May 20, 1978, the enzordance with the provisions of the Federal Food, Drug, devices that have been reclassinod in acceraarroval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmelle Act (Act) that do not require approvide controls provisions of the Act. The You may, therefore, market the devices, bacted to annual registration, listing of general Controls provisions of the fisc labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), II your device is classifica (see above) and stime major regulations affecting your device can be it may be subject to additional controlial shoulding may only of the 898. In addition, FDA may found in the Code of I sacrains concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 Issualled of a backware of a back other requirements of the Act that I DA has made a acterinations administered by other Federal agencies. You must of any Federal statures and roganitients, including, but not limited to: registration and listing comply with an the Act 3 requirements, in 801); good manufacturing practice requirements as set (21 CFR Patt 807), laocime (21 OFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

: 上

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_KO 13086

Device Name:__________________________________________________________________________________________________________________________________________________________________

## Indications For Use:

WET® Light Personal Moisturizer is intended for whi Bight refections . It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off
Division of Reproductive, Assisted,
and Radiological Devices K013086
510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)