# K991258: Novus Verdi Delivery Systems

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: May 13, 1999 after 30 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: 1 generation back to K812219 (1981). 4 ancestors in all.
296 later devices descend from it; 5 cite it directly.
0 of 301 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960867: Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag Photocoagulator (Evergreen 532), B.V. Intl. S.A. (1996) Summary page 1.
- K913127: Coherent Novus 3000 Argon Photocoagulator, Coherent Medical Group (1991) Summary page 1.
- K885196: Laser Indirect Ophthalmoscope (Lio), Coherent Medical Group (1989) Summary page 1.
- K812219: Model 900S Intraocular Probe, Lumenis, Inc. (1981) Summary page 1.

## Most influential descendants
- K050738: FT Fiber Optic Delivery Systems (2005), 225 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own

## Indications for use
Clinical Indications with a Slit Lamp Delivery System This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including: Proliferative Diabetic retinopathy, macular degeneration, and retinal detachment. Clinical Indications with a Laser Indirect Ophthalmoscope Delivery System This system has the same clinical indications as the slit lamp delivery system, but it can only be used for peripheral photocoagulation. Clinical Indications with an Endophotocoagulation (EPCP) Delivery System The EPCP probe has been designed as a means for intraocular photocoagulation as an adjunct to vitrectomy surgery. Specific indications for use for the EPCP include treatment of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, and various retinal vascular tumors.

Source page: https://510kreport.com/device/K991258
Methodology: https://510kreport.com/methodology