21 CFR 890.5500
Infrared lamp
21 CFR 890.5500 is the regulation titled “Infrared lamp” in 21 CFR Part 890, Physical Medicine Devices. Since 2021, 6 FDA warning letters have cited it.
- Letters citing it
- 6 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 3 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 6 letters
- Closed out
- 33% of these letters have a published close-out
Letters citing it, by year issued
Most are medical device letters (5 of 6). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 890.5500 (eCFR, as of Sep 1, 2026)
(a) Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.
(b) Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.5500.
- 21 CFR 807.81When a premarket notification submission is required6 letters cite both
- 21 CFR 890.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)6 letters cite both
- 21 CFR 820.198Complaint files5 letters cite both
- 21 CFR 820.20Management responsibility4 letters cite both
- 21 CFR 820.22Quality audit4 letters cite both
- 21 CFR 820.30Design controls4 letters cite both
- 21 CFR 820.50Purchasing controls4 letters cite both
- 21 CFR 820.90Nonconforming product4 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 890.5500 that FDA posted most recently.
- DevicesView Technological Medical Advancements LLCDiowave 250 WLS and Diowave 100 WLS laser systemsIssuedSep 26, 2025PostedOct 7, 2025
- DevicesView Spectra Therapy, LLCTherapeutic heating infrared lamps (LASERwrap system)IssuedJul 22, 2025PostedAug 12, 2025
- DevicesView Mectronic Medicale S.R.L.Therapeutic RF, laser, and laser/cryotherapy devicesIssuedJun 27, 2025PostedAug 5, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.