# K050274: Diodent II Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Hoya Photonics, Inc.
- Decided: Apr 29, 2005 after 81 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.
297 later devices descend from it; 2 cite it directly.
0 of 298 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) DioDent Dental Laser System: named in the summary without a submission number
- (no number) LVllase: named in the summary without a submission number
- (no number) Aurora: named in the summary without a submission number
- (no number) Twilite: named in the summary without a submission number
- (no number) Dentek LD-15 Diode Laser System: named in the summary without a submission number
- (no number) DioLase ST: named in the summary without a submission number
- (no number) Dental Diode Laser: named in the summary without a submission number

## Most influential descendants
- K061898: Ezlase (2007), 289 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own

## Indications for use
For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Sucular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.

Source page: https://510kreport.com/device/K050274
Methodology: https://510kreport.com/methodology