# HLQ: Keratoscope, Ac-Powered

- Device class: 1; regulation: 21 CFR 886.1350; FDA's rule: 510(k) exempt
- FDA decisions: 29
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1987: 2
- 1989: 2
- 1990: 4
- 1991: 3
- 1992: 1
- 1993: 2
- 1994: 3
- 1995: 1
- 1997: 2
- 2001: 1

## Most-cited predicates
- K003299: Opd-Scan, Models Ark-10000 and Ark-9000 (2001), cited by 2
- K944207: Topographic Modeling System 2 TMS-2 (1994), cited by 1
- K781994: Autokeratometer, Instrument (1979), cited by 1
- K940647: Orbscan (TM) Keratometer (1994), cited by 1
- K944616: Keratron Corneal Topographer (1994), cited by 1

Source page: https://510kreport.com/product-code/HLQ
Data by year (CSV): https://510kreport.com/product-code/HLQ.csv