# K062336: Optimedica Laser Indirect Ophthalmoscope

- Pathway: 510(k) (Traditional)
- Applicant: Optimedica Corporation
- Decided: Oct 19, 2006 after 70 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K894841 (1989). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924588: Zeiss Laser Indirect Ophthalmoscope, Carl Zeiss, Inc. (1993) Summary page 1.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.
- K052526: Novus 3000 Laser System and Delivery Devices, Lumenis, Inc. (2005) Summary page 1.
- K991258: Novus Verdi Delivery Systems, Lumenis, Inc. (1999) Summary page 1.

## Most influential descendants
- K123056: Pascal Laser Indirect Ophthalmoscope (2012), 0 descendants of its own

## Indications for use
The OptiMedica LIO is indicated for the delivery of laser energy in eyes with retinal pathology. The OptiMedica LIO is indicated for use in the following ophthalmic treatments and conditions: * Diabetic retinopathy (panretinal photocoagulation) * Macular degeneration * Peripheral neovascularization * Retinal breaks * Retinal detachments * Retinal tears * Lattice degeneration * Pneumatic retinopexy reattachment procedures * Segmental peripheral photocoagulation * Segmental photocoagulation * Cloudy vitreous cavities * Pediatric retinal repairs (under general anesthesia) * Delivery of laser energy through small pupils or to eyes with focal lens opacities

Source page: https://510kreport.com/device/K062336
Methodology: https://510kreport.com/methodology