Laser, Dental, Soft Tissue
General, Plastic Surgery · 21 CFR 878.4810
Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.
Recent MDR events
5 adverse event reports on file
- DEKA SMARTPERIODec 11, 2024InjuryEl.en. Electronic Engineering S.p.a.3001431138-2024-00018
- LIFEVEST WCD 4000 SYSTEMApr 24, 2015InjuryZoll Manufacturing Corporation3008642652-2015-02400
- LIFEVEST WCD 4000 SYSTEMApr 10, 2015MalfunctionZoll Manufacturing Corporation3008642652-2015-01730
- LIFEVEST WCD 4000 SYSTEMMar 30, 2015MalfunctionZoll Manufacturing Corporation3008642652-2015-01636
- LIFEVEST WCD 3000 SYSTEMFeb 26, 2015MalfunctionZoll Manufacturing Corporation3008642652-2015-01032
Event type breakdown
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Trend for “Inappropriate/Inadequate Shock/Stimulation”
No history to chart.
Recalls
2 recall events for this product code
- Convergent DentalOpen, ClassifiedNov 17, 2023
Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked
It has been found that potential unintended laser activation can occur without foot pedal depression.
Z-0324-2024 · View FDA record ↗ - Zap Lasers LLCTerminatedJan 21, 2010
SoftLase Pro Dental Lasers: Zap SoftLase, SoftLase Pro, OrthoLase, and HygieneLase models, Model numbers ZA-SLP, ZA-ORT, ZA-HYG, G22002SLP, ZA-SOFTLASE2WSII, Z
The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule.
Z-0587-2010 · View FDA record ↗
Registered firms
23 firms currently registered for this product code
Dentlight Inc.
Plano, TX, US
Gigaalaser Company Ltd.
Wuhan Hubei, CN
Shenzhen Soga Technology Co., Ltd.
Shenzhen Guangdong, CN
Biolase Mg Llc
Corona, CA, US
Fotona D.o.o.
LJUBLJANA, SI
Medency Srl
Vicenza Veneto, IT
El.en. Electronic Engineering Spa
CALENZANO Firenze, IT
Brasseler U.s.a. Dental, Llc
SAVANNAH, GA, US
Guilin Woodpecker Medical Instrument Co., Ltd
GUILIN CITY Guangxi, CN
Shanghai Wonderful Opto-electrics Tech. Co., Ltd
Shanghai, CN
Azena Medical
Walnut Creek, CA, US
Nordent Mfg., Inc.
ELK GROVE VILLAGE, IL, US
Goldendent
Roseville, MI, US
Cao Group, Inc.
W Jordan, UT, US
Shofu Dental Corp.
SAN MARCOS, CA, US
All Quality & Services, Inc.
Fremont, CA, US
Biolase Mg Llc
Foothill Ranch, CA, US
Convergent Dental
Waltham, MA, US
Cao (china) Medical Equipment Company, Limited
LANGFANG, HEBEI, CN
510(k) clearances
17 clearances for this product code
- Shenzhen Soga Technology Co., Ltd.May 19, 2026
K253309 · SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
- Azena Medical, LLCMar 10, 2026
K260765 · Gemini NOVA 810+980 Soft Tissue Laser
- Matelaser, Inc.Oct 16, 2025
K250731 · MateLaser Medical Diode Laser Systems (ML-DLS-30)
- Wuhan Pioon Technology Co., Ltd.May 8, 2025
K243764 · Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
- Gigaalaser Company , Ltd.Mar 4, 2024
K230047 · Medical Diode Laser Systems
- Shanghai Wonderful Opto-Electrics Tech.Co.,LtdFeb 28, 2024
K232885 · Dawn Diode Laser System
- Medency S.R.L.Nov 27, 2023
K232222 · Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
- Convergent Dental, Inc.Sep 14, 2022
K221761 · Solea