Product code HOI— Ophthalmic
BRILLETTE MODEL
- Classification name
- Spectacle, Magnifying
- Device class
- Class 1
- Regulation
- 21 CFR 886.5840
- Advisory panel
- Ophthalmic
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code HOI
FDA has cleared devices under product code HOI between 1980 and 1994, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1993
- 1991
- 1986
- 1985
- 1984
- 1982
- 1980
Top applicants under product code HOI
Recent clearances under product code HOI
- K943613 — NIL
- K930435 — SPECTACLE FRAMES
- K931328 — PYRAMID SUNGLASSES/PYRAMID READING GLASSES
- K910329 — SUNGLASSES
- K854854 — SYSTEMS OF SIGHT LOW VISION EYEWARE
- K844716 — MAGNIFYING SPECTACLES W/PLASTIC LENSES
- K844038 — VISITEC MAGNIFYING SPECTACLES
- K842835 — BRILLETTE MODEL
- K820732 — LA VEL LATERAL VIEW EXTENSION LENS
- K813548 — UVEX MINI-SPECS
- K801733 — FENZL RETICLE
Data sourced from openFDA. This site is unofficial and independent of the FDA.