Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed: - Excision and incision biopsies - Hemostatic assistance - Treatment of apthous ulcers - Frenectomy - Frenotomy - Gingival incision and excision - Gingivectomy - Gingivoplasty - Incising and draining abscesses - Operculectomy - Oral papillectomy - Removal of fibromas - Soft tissue crown lengthening - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) - Tissue retraction for impression - Photo initiation of gingival barriers and dams - Laser-assisted bleaching/whitening of teeth
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed: Excision and incision biopsies, Hemostatic assistance, Treatment of apthous ulcers, Frenectomy, Frenotomy, Gingival incision and excision, Gingivectomy, Gingivoplasty, Incising and draining abscesses, Operculectomy, Oral papillectomy, Removal of fibromas, Soft tissue crown lengthening, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), Tissue retraction for impression, Photo initiation of gingival barriers and dams, Laser-assisted bleaching/whitening of teeth.
The VIAX Dental Lab LUCERNA VDL980-1 Portable Diode Laser is comprised of three basic parts: The control box ('control module') with microprocessor and user interface for selection of modes: (a) Procedural (continuous wave or pulsed) 980nm laser output (b) Curing (dental photo initiated materials) at 450nm (+/-10nm) with timed outputs of 1,3, and 5 second(s) of output duration; and (c) Whitening procedures at 450nm (+/-10nm) timed to provide 15 minute durational output(s); A touch screen LCD display to provide visual indications of power settings and of the unit's status, and accept inputs via the touch screen to select modes and operational parameters and adjust / set and features the units power ON/OFF functions, Application of user PIN number for operation and initialization, Selection of Language (English, Spanish, Portugese) and System settings (PIN/Password setting); the Second component is the laser handpiece that houses the laser working beam and aiming beam fiber optic component(s) and the disposable fiberoptic tip assemblies (Procedural, Curing, and Whitening). Two optional footswitches are available that can be used to activate the laser working beam: (a) Corded that plugs into the back of the system unit and (optional) wireless footswitch. Electrical power is taken from the AC/DC 12 vdc Power Supply that plugs into a standard electrical outlet and charges the L-ion 7.2VDC battery at 24W, a 7,2 VDC lithium-ion battery that generates 4 amps used to drive the diode laser(s) and system overhead.Summary parsed at:2026-06-01 06:06:20 UTC