ILYClass II
Lamp, Infrared, Therapeutic Heating
21 CFR 890.5500 / Physical Medicine
ILY is the FDA product code for Lamp, Infrared, Therapeutic Heating, a class II device type, regulated under 21 CFR 890.5500. As of , FDA records hold 229 510(k) clearances under this code, the most recent dated , and 20 recalls.
Classification record
- Product code
- ILY
- Device name
- Lamp, Infrared, Therapeutic Heating
- Regulation
- 21 CFR 890.5500
- Device class
- Class II
- Review panel
- Physical Medicine
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 229
- Ingested recalls
- 20
Clearances, product code ILY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 1 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 2 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 4 |
| 1998 | 4 |
| 1999 | 3 |
| 2000 | 5 |
| 2001 | 2 |
| 2002 | 9 |
| 2003 | 11 |
| 2004 | 14 |
| 2005 | 23 |
| 2006 | 12 |
| 2007 | 10 |
| 2008 | 16 |
| 2009 | 13 |
| 2010 | 8 |
| 2011 | 9 |
| 2012 | 11 |
| 2013 | 9 |
| 2014 | 11 |
| 2015 | 11 |
| 2016 | 8 |
| 2017 | 5 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code ILY| Applicant | Clearances |
|---|---|
| USA Laser Biotech, Inc. | 6 |
| Cynosure, LLC | 4 |
| Dynatronics Corp. | 4 |
| Escada International, Inc. | 4 |
| Meditech International Inc | 4 |
| Medx Electronics, Inc. | 4 |
| Biophotas, Inc. | 3 |
| Bioscan, Inc. | 3 |
| Eltech S.R.L | 3 |
| Foshan Gaunying Electronics Co., Ltd | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 3H Co.,Ltd
- 528 Innovations LLC
- Advance-Esthetic LLC
- Aesthetic Technology Ltd
- Aimi Health Technology (Guangdong) Co., Ltd.
- Airnergy International GmbH
- All Quality & Services, Inc.
- Alma Lasers Ltd.
- Amorepacific
- Ample Mega Electronic Technology (Dongguan) Co., Ltd
- Anhui CHR Software Technology Limited Company
- Anodyne Therapy, LLC
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.
