# LOI: Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 10
- 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)
- 1984: 3
- 1985: 16
- 1986: 16
- 1987: 18
- 1988: 5
- 1989: 4
- 1990: 2
- 1991: 1
- 2000: 1

## Most-cited predicates
- P840012: Microruptor MR-2 ND:Yag Laser System (1986), cited by 1
- P830054: Neodymium: Yag Ophthalmic Laser System 9900 (1984), cited by 1

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