FTCClass II
Light, Ultraviolet, Dermatological
21 CFR 878.4630 / General, Plastic Surgery
FTC is the FDA product code for Light, Ultraviolet, Dermatological, a class II device type, regulated under 21 CFR 878.4630. As of , FDA records hold 272 510(k) clearances under this code, the most recent dated , and 15 recalls.
Classification record
- Product code
- FTC
- Device name
- Light, Ultraviolet, Dermatological
- Regulation
- 21 CFR 878.4630
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 272
- Ingested recalls
- 15
Clearances, product code FTC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 6 |
| 1979 | 1 |
| 1980 | 4 |
| 1981 | 14 |
| 1982 | 4 |
| 1984 | 27 |
| 1985 | 52 |
| 1986 | 39 |
| 1987 | 16 |
| 1988 | 5 |
| 1989 | 8 |
| 1990 | 7 |
| 1991 | 2 |
| 1992 | 4 |
| 1993 | 4 |
| 1994 | 2 |
| 1995 | 6 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 6 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 5 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 2 |
Applicants with the most clearances
Product code FTC| Applicant | Clearances |
|---|---|
| National Biological Corp. | 27 |
| The Daavlin Distributing Co. | 17 |
| Philips Int'L B.V. | 9 |
| Light Sources, Inc. | 8 |
| Mottek Intl. Corp. | 8 |
| Avex Industries, Ltd. | 6 |
| Philips Lighting Co. | 6 |
| Psoralite Corp. | 5 |
| Tannhut | 5 |
| Medical Device Consultants, Inc. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Aerolase Corporation
- Alma Lasers Ltd.
- Apk Technology Co., Ltd
- Boston Aesthetics Inc
- Chongqing Peninsula Medical Technology Co., Ltd.
- Clarteis
- German Medical Engineering GmbH
- Global Fabtech Wheel Chair (Shanghai) Co., Ltd.
- Hi-Tech Products de Mexico S.A. de C.V.
- KBD, Inc.
- Laser Marketing Group, LLC
- Medicol USA, Inc
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
