# K022327: Novus Spectra

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Oct 16, 2002 after 90 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
No predicates in its family tree.
104 later devices descend from it; 7 cite it directly.
0 of 105 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Elite Solid State Green Diode Pumped 532nrn: named in the summary without a submission number
- (no number) Elite Ultra Solid State Green Diode Pumped 532nm: named in the summary without a submission number
- (no number) Corium 200 Solid State Green Diode Pumped 532nm: named in the summary without a submission number
- (no number) Corium 400 Solid State Green Diode Pumped 532nm: named in the summary without a submission number

## Most influential descendants
- K050562: Oculight GL/GLX (2005), 75 descendants of its own
- K062369: Iridex Oculight TX (2006), 73 descendants of its own
- K091534: Lightlas Model 532 (2009), 72 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own

## Indications for use
Ophthdmolom Retinal Photocoagulation Trabeculoplosty Iridotomy Diabetic retinopathy Peripheral Iridectomy Posterior and Anterior procedures Senile macular degeneration Eat. Nose and Throat E m Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in MicroMmo Otologic Proccdures Dermatolom Pigmented lesions, including soar lentgine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectasias,including facial and leg telangiectasias Cutaneous lesions Flat warts Dermatosis Papulosa Nigra Dentism Frenectomy Treatment of Oral Mucous Cyst Treatment of Benign Vascular Lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillarykavernous hcmangbmas Lymphangioma AV malformation of the tongue Hemangio1ymphangiomas Photocoagulation of supeficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/ gingivectomy Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (DNg. Initation, Epulus,.. .) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Frce Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sore%, herpetic lesions, and aphthous ulcers Laser-assisted bleachindwhitening

Source page: https://510kreport.com/device/K022327
Methodology: https://510kreport.com/methodology