21 CFR 886.4250
Ophthalmic electrolysis unit
21 CFR 886.4250 is the regulation titled “Ophthalmic electrolysis unit” in 21 CFR Part 886, Ophthalmic Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 801.20, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
The regulation
Read the text of 21 CFR 886.4250 (eCFR, as of Sep 1, 2026)
(a) Identification. An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.
(b) Classification. (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001; 84 FR 71817, Dec. 30, 2019]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 886.4250.
- 21 CFR 801.20Label to bear a unique device identifier1 letter cites both
- 21 CFR 806.10Reports of corrections and removals1 letter cites both
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 820.100Corrective and preventive action1 letter cites both
- 21 CFR 820.184Device history record1 letter cites both
- 21 CFR 820.198Complaint files1 letter cites both
- 21 CFR 820.22Quality audit1 letter cites both
- 21 CFR 820.25Personnel1 letter cites both
Latest letters citing it
The letter citing 21 CFR 886.4250 that FDA posted most recently.
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