FDA product code ILY: Lamp, Infrared, Therapeutic Heating
ILY is the FDA product code for lamp, infrared, therapeutic heating. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel. FDA has cleared 229 510(k) submissions under ILY, 6 in the last five years, from 167 different applicants. The average 510(k) review took 168 days (median 151); 272 days on average over the last three years. FDA has posted 19 recalls for ILY devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lamp, Infrared, Therapeutic Heating |
| Device class | Class II |
| Regulation | 21 CFR 890.5500 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
510(k) clearances per year for ILY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 134 |
| 2020 | 1 | 147 |
| 2022 | 2 | 203 |
| 2023 | 1 | 93 |
| 2024 | 1 | 468 |
| 2025 | 1 | 249 |
| 2026 | 1 | 98 |
Top ILY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Usa Laser Biotech, Inc. | 6 | 2016-07-26 |
| Cynosure, Inc. | 4 | 2013-05-02 |
| Dynatronics Corp. | 4 | 2012-02-09 |
| Meditech International, Inc. | 4 | 2008-12-18 |
| Medx Electronics, Inc. | 4 | 2008-10-01 |
162 more applicants have ILY clearances. See the full list in Caduvo.
Most recent ILY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253965 | Wuhan PHOMED Technology Company , Ltd. | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | 2026-03-19 | 98 |
| K242755 | Gigaalaser Company , Ltd. | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | 2025-05-19 | 249 |
| K231997 | Cure Point Therapeutics, Inc. | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | 2024-10-15 | 468 |
| K223642 | Light Tree Ventures Europe B.V. | LED Lip Perfector, model: ZC-05 | 2023-03-09 | 93 |
| K221189 | Ltbio Co., Ltd. | OLIZ LTB-1000A | 2022-08-29 | 126 |
Recalls for ILY devices
19 product recalls in 11 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2026-01-09.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2025 | 4 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code ILY?
ILY is the FDA product code for lamp, infrared, therapeutic heating. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel.
What device class is ILY?
Class II, regulation 21 CFR 890.5500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ILY?
Across 229 cleared submissions the average was 168 days from receipt to decision (median 151).
Which companies have the most ILY clearances?
Usa Laser Biotech, Inc. (6); Cynosure, Inc. (4); Dynatronics Corp. (4); Meditech International, Inc. (4); Medx Electronics, Inc. (4).
Have ILY devices been recalled?
Yes: 19 product recalls across 11 recall events; the most recent began 2026-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code ILY
- Run a recall and safety report across every ILY manufacturer
- Watch product code ILY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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