Prodigy Superpulse Nd:yag Surgical Laser Systems & Accessories

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K951935 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Genera 100 Surgical System

  Class II

  FDA 510(k) K945181 Active Cleared 20 Jan 1995

• Opticon Connector Adapter II

  Class II

  FDA 510(k) K942759 Active Cleared 31 Aug 1994

• Optica 60 Nd:YAG Surgical Laser System

  Class II

  FDA 510(k) K912703 Active Cleared 11 Oct 1991

• Protege II Er: Yag Laser System and Accessoies (Upgrade)

  Class II

  FDA 510(k) K981627 Active Cleared 31 Jul 1998

• Optilite (Tm) VII Fiberoptic Accessories Rotalase (Tm) Angle Delivery Systemsn and Accessories

  Class II

  FDA 510(k) K944704 Active Cleared 6 Jan 1995

• Optica 120 Nd:yag Surgical Laser System

  Class II

  FDA 510(k) K901710 Active Cleared 20 Sep 1990

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