# K991840: Fresco Phosphene Tonometer and or Phosphene Tonometer and or FPT and or Eyelid Tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Bernard B. Fresco
- Decided: Mar 20, 2000 after 297 days
- Product code: HKY (Tonometer, Manual)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Clinical testing of intraocular pressure. Self testing of intraocular pressure. Home monitoring of intraocular pressure. Screening studies, and outreach clinics. For Glaucoma, Ocular hypertensive, and general population groups.

Source page: https://510kreport.com/device/K991840
Methodology: https://510kreport.com/methodology