# K990174: Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV

- Pathway: 510(k) (Traditional)
- Applicant: Fisma, Inc.
- Decided: Apr 1, 1999 after 72 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.
32 later devices descend from it; 3 cite it directly.
0 of 33 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) Continuum Biomedical, Inc., CB/Diode/532 Laser System: named in the summary without a submission number
- (no number) Laserscope, Aura Laser System: named in the summary without a submission number
- (no number) Iris Medical DioLite 532: named in the summary without a submission number

## Most influential descendants
- K021975: Lasersystem Beautystar 532 (2002), 24 descendants of its own
- K042496: Adept Ultralite 532 Laser (2004), 23 descendants of its own
- K063396: Velure Family of Diode Lasers and Delivery Device Accessories (2007), 22 descendants of its own
- K100143: Pilot Diode Laser, Model 002-00139 (2010), 20 descendants of its own
- K123443: Precise SHP Diode Laser (2013), 9 descendants of its own

## Indications for use
Ophthalmology: (Atlas-Elite, Elite Ultra) »Retinal Photocoagulation »Trabeculoplasty »Iridotomy »Diabetic Retinopathy »Peripheral Iridectomy »Posterior and Anterior procedures Ear, Nose, & Throat (ENT): 'Atlas-Elite, Elite Ultra »Stapedectomy »Stapedotomy »Myringotomies »Lysis of Adhesions »Control of Bleeding *Removal of Acoustic Neuromas »Soft Tissue Adhesion in Micro/Macro Otologic procedures *(Elite Ultra [4.0 Watt] only)* *Epistaxis (HHT)* *Partial Turbinate Reduction* *Vaporization/Coagulation of Granulation Tissue* *Photocoagulation or Vaporization of Soft or Fibrous Tissue* Dermatology: (Atlas-Elite, Elite Ultra, Corium 200, & Corium 400) »Pigmented Lesions, inc. solar lentigines »Vascular Lesions, inc. cherry hemangiomas & ongiockeratomas »Extremities Telangiectasias, inc. facial & leg telangiectasias »Cutaneous Lesions »Flat Warts »Dermatosis »Papulosa Nigra Dentistry »Frenectomy »Treatment of Oral Mucous Cysts »Treatment of Benign Vascular Lesions: »Capillary Hemangioma »Hemorrhagic Hereditary Telongiectasia »Capillary/Cavernous Hemangiomas »*Lymphangioma »AV Malformation of the Tongue »Hemangiolymphangiomas »Photocoagulation of Superficial Vessels »Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels »Treatment of Superficial Tongue Lesions »Tissue Management and Hemostasis for Crown end Bridge Impressions *»Incision and Drainage for Abscess »Gingivoplasty/Gingivectomy: »Operative Procedures »Crown and Bridge, Gingival Retraction »Crown Lengthening »Hyperplasia (Drug, Irritation, Epulis, ...) »Hemostasis during Dental Procedures »*Operculectomy (Operculotomy) »Excisional Biopsy »Free Gingival Graft (Adjunct): »Hemostasis of Donor Site »Hemostasis of Graft Site »Vestibuloplasty »Soften Gutta Percha »Treatment of Canker Sores, Herpetic Lesions, and Aphthous Ulcers »Laser-assisted bleaching/whitening

Source page: https://510kreport.com/device/K990174
Methodology: https://510kreport.com/methodology