Cleared Traditional

K013086 - WET LIGHT PERSONAL MOISTURIZER (FDA 510(k) Clearance)

K013086 · Trigg Laboratories, Inc. · Obstetrics & Gynecology device

Dec 2001

Decision

90d

Days

Class 2

Risk

K013086 is an FDA 510(k) clearance for the WET LIGHT PERSONAL MOISTURIZER. This device is classified as a Condom (Class II - Special Controls, product code HIS).

Submitted by Trigg Laboratories, Inc. (Woodland Hills, US). The FDA issued a Cleared decision on December 13, 2001, 90 days after receiving the submission on September 14, 2001.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K013086 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 2001
Decision Date	December 13, 2001
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement