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Ophthalmic Femtosecond Laser

FDA product code OOE · 38 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 886.4390
Review panel
OP
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-08-14 – 2025-09-24

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

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