FDA product code OOE
Ophthalmic Femtosecond Laser
Ophthalmic·Class 2·21 CFR 886.4390
US regulatory classifications
- US Product Code (FDA)
- OOEView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 886.4390View CFR Regulation →
- Medical specialty
- Ophthalmic
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
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About this record
Ophthalmic Femtosecond Laser is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.