# HHR: Laser, Surgical, Gynecologic

- Device class: 2; regulation: 21 CFR 884.4550; FDA's rule: 510(k) required
- FDA decisions: 48
- 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)
- 1977: 2
- 1979: 1
- 1980: 2
- 1981: 1
- 1982: 1
- 1985: 6
- 1986: 14
- 1987: 8
- 1988: 12
- 1989: 1

## Most-cited predicates
- K872254: SLT Contact ND:Yag Laser for Intra-Abdom.&Genital (1987), cited by 1
- K872253: Contact ND:Yag Laser for Treatment of Menorrhagia (1987), cited by 1

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