Laser, Dental, Soft Tissue

Product Code: NVK

General & Plastic Surgery Medical Laser Products

Definition: Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as NVK

1396Laser, Dental, Soft TissueLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

1396Laser, Dental, Soft TissueLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Laser, Dental, Soft Tissue [30278]21 CFR §878.4810 🔎
Laser, Dental, Soft Tissue [38651]21 CFR §878.4810 🔎
Laser, Dental, Soft Tissue [38649]21 CFR §878.4810 🔎
Laser, Dental, Soft Tissue [38650]21 CFR §878.4810 🔎
Laser, Dental, Soft Tissue [34006]21 CFR §878.4810 🔎

Pre-market Notifications for NVK

K221761SoleaConvergent Dental, Inc.
K213658DEKA SMARTPERIOEl.En Electronic Engineering Spa
K213428EdgeProBiolase Inc.
K211150Dental Diode Laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.
K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC
K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.
K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentLight Inc.
K030146KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+KAVO AMERICA

Global Unique Device Identification Database

00860179001044Laser, Dental, Soft Tissue
00850010501086Laser, Dental, Soft Tissue
00850010501079Laser, Dental, Soft Tissue
00850010501062Laser, Dental, Soft Tissue
00850010501130Laser, Dental, Soft Tissue
00850010501123Laser, Dental, Soft Tissue
00850010501116Laser, Dental, Soft Tissue
E2352171B1Laser, Dental, Soft Tissue
00818365026722Laser, dental, soft tissue
10818365026712Laser, dental, soft tissue
10818365026705Laser, dental, soft tissue
10818365026699Laser, dental, soft tissue
10818365026682Laser, dental, soft tissue
10818365026675Laser, dental, soft tissue
10818365026668Laser, dental, soft tissue

Maude Adverse Events

LIFEVEST WCD 4000 SYSTEMZOLL MANUFACTURING CORPORATION2015-04-24
LIFEVEST WCD 4000 SYSTEMZOLL MANUFACTURING CORPORATION2015-04-10
LIFEVEST WCD 4000 SYSTEMZOLL MANUFACTURING CORPORATION2015-03-30
LIFEVEST WCD 3000 SYSTEMZOLL MANUFACTURING CORPORATION2015-02-26
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.