The UNITY VCS and UNITY CS consoles are indicated for use during various ophthalmic surgeries, including phacoemulsification, vitreoretinal surgery, photocoagulation, iridotomy, and trabeculoplasty procedures.
Indications for Use
The UNITY VCS and UNITY CS consoles are indicated for use during anterior segment (phacoemulsification and removal of cataracts) and posterior segment (vitreoretinal) ophthalmic surgery.
Type of Use
The UNITY VCS and UNITY CS consoles are indicated for Prescription Use (21 CFR 801 Subpart D).
Additional Information
Please note that the UNITY VCS and UNITY CS consoles are subject to quality system regulation (21 CFR Part 820) and must comply with all applicable FDA regulations.
Manual:
Download: 510(k) Summary: K233876 UNITY VCS, UNITY CS
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