# K983058: Ceralas D Laser System, Model # Ceralas D15

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Oct 21, 1998 after 50 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: 2 generations back to K922901 (1992). 8 ancestors in all.
208 later devices descend from it; 6 cite it directly.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951775: Ceralas Diode Laser System (Model Ceralas D50), Ceram Optec, Inc. (1995) Summary page 1.
- K964497: Ceralas Diode Laser System (Ceralas D15), Ceram Optec, Inc. (1997) Summary page 1.
- K954316: Aurora Surgical Diode Laser System W/Accessories, Premier Laser Systems, Inc. (1995) Summary page 2.
- K974586: Aurora Diode Laser System, Premier Laser Systems, Inc. (1998) Summary page 2.
- K972325: Pulsemaster 1000 ST Dental Laser System, American Dental Technologies, Inc. (1997) Summary page 2.
- K961269: Pulsemaster, American Dental Technologies, Inc. (1997) Summary page 2.
- K961136: Pulsemaster, American Dental Technologies, Inc. (1996) Summary page 2.

## Most influential descendants
- K991891: Ceralas Diode Laser System, Model Ceralas D15 (1999), 207 descendants of its own
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25 (2008), 153 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K053161: Sirolaser (2006), 79 descendants of its own

## Indications for use
The Ceralas D Laser System is indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva): frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; leukoplakia; removal of hyperplastic tissues; treatment of aphthous ulcers; and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

Source page: https://510kreport.com/device/K983058
Methodology: https://510kreport.com/methodology