# Ophthalmic Femtosecond Laser
> **Product code: OOE** · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.4390
## Classification
- **FDA Product Code:** OOE
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 886.4390
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.

## Market data
- **Cleared 510(k) submissions:** 47
- **Registered establishments:** 30
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OOE)
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