# K032357: Novus TTX Laser and Delivery Devices with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Oct 9, 2003 after 71 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: 3 generations back to K894841 (1989). 30 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020374: Oculight SL/SLX, Iridex Corp (2002) Summary page 1.
- K913430: Iris Oculight (R) SLX, Iriderm Div. (1991) Summary page 1.
- K912918: Iris Oculight Diode Laser Adding Slit Lamp Adapter, Iriderm Div. (1991) Summary page 1.
- K013760: DC-3300 Laser Diode Photocoagulator, Nidek, Inc. (2002)
- K903639: Nidek DC-3000 Diode Laser Photocoagulator, Nidek, Inc. (1991) Summary page 1.
- K960867: Frequency Doubled ND:Yag Photocoagulator (Viridis) Frequency Doubled ND:Yag Photocoagulator (Evergreen 532), B.V. Intl. S.A. (1996) Summary page 1.
- K830235: Franzen Needle Guide, Precision Dynamics Corp. (1983) Summary page 1.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.
- K973470: Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in Combination with the Coherent Argons, Lumenis, Inc. (1997) Summary page 1.
- K840590: Fleischman-Swartz Endo-Ocular Probe, Hgm, Inc. (1984) Summary page 1.
- K860358: Fleischman-Swartz Endo-Ocular Probe (Sterile), Hgm, Inc. (1986) Summary page 1.

## Cited in the summary but kept off the family tree
- K960097: Chartr EP, Ics Medical Corp. (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K052526: Novus 3000 Laser System and Delivery Devices (2005), 4 descendants of its own
- K062336: Optimedica Laser Indirect Ophthalmoscope (2006), 1 descendant of its own
- K061025: Accutech Endolite Probe (2006), 1 descendant of its own
- K123056: Pascal Laser Indirect Ophthalmoscope (2012), 0 descendants of its own
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own

## Indications for use
The Novus TTx Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Novus TTx is indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - Diabetic retinopathy (proliferative retinopathy, nonproliferative retinopathy, macular edema); - Retinal tears, detachments and holes - Lattice degeneration - Age-related macular degeneration - Intraocular tumors (choroidal hemangioma, choroidal melanoma, retinoblastoma) - retinopathy of prematurity - choroidal neovascularization; - central and branch retinal vein occlusion; Iridotorny, iridectomy and trabeculoplasty in angle closure glaucoma and openangle glaucoma Laser Indirect Ophthalmoscope The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia). Endophotocoagulation The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

Source page: https://510kreport.com/device/K032357
Methodology: https://510kreport.com/methodology