Sharplan Lasers, Inc.

United StatesFDA applicant, unverified

Devices: 78

What Sharplan Lasers, Inc. makes

Sharplan Lasers, Inc. manufactures CO₂ surgical lasers, including sealed-off and vaporization models, as well as Nd:YAG lasers designed for ENT and neck surgery. Their portfolio also includes remote control units, endoscopic and surgical video cameras, and synthetic contact tips for general use. Specialized accessories like lateral Nd:YAG fibers and CO₂ laser endpieces are part of their offerings.

The company’s devices are regulated under FDA Class II, Class III, and Unclassified (U) classifications, with most products cleared via the 510(k) pathway. Their products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Sharplan Lasers, Inc.

What Sharplan Lasers, Inc. makes

Catalogue78

Sharplan Lasers, Inc. Silktouch CO2 Flash Scanner Ref K961935

Sharplan 719Y Microslad(Tm) Ref K881887

Sharplan Model 3100 Nd:yag Surgical Laser System Ref K951165

Sharplan Erbium: Yag Laser (4020) Ref K971648

Sharplan Model Ultra Ultrasonic Surg Aspirator Ref K913848

Sharplan Medilas Model 40 N For Urological Use Ref K871348

Sharplan Models 719-O Colposlad CO2 Su Micromani. Ref K881952

Sharplan Model 1020 CO2 Surgical Laser System Ref K860087

Sharplan Models 20C, 30C, And 40C CO2 Lasers Ref K963229

Sharplan Usight 9010 Laparoscopic Ultrasound System Ref K945796

Sharplan Series 2900 Synthetic Contact Tips Ref K894211

Modified Labeling & Packaging Of Sharplan 2100 Ref K890040

Sharplan Ruby Laser System Ref K962446

Sharplan 2100 Nd:yag Laser, Series 2900 Syn. Tips Ref K883563

Sharplan Flexible CO2 Surgical Laser Applicator Ref K900076

Sharplan Nd:yag Disposable Fiber Delivery System Ref K900153

Sharpulse Ref K923855

Sharplan Nd:yag Laser For Arthroscopy/Meniscectomy Ref K896762

Sharplan Model 1055 Sealed CO2 Surgical Laser Ref K900592

Sharplan Lasers, Inc Silktouch 2 Flash Scanner Ref K955621

Sharplan Model 1120 CO2 Surgical Laser Ref K936109

Sharplan Ultra Laparoscopic Handpiece Ref K960040

Sharplan 1075 CO2 Laser Ref K893206

Sharplan 4300 & 4310 Ultrasonic Surgical Apirators Ref K883091

Sharplan Combined CO2/Nd:yag Laser Micro. #749 Ref K890059

Sharplan Nd:yag Surg.laser, Model 3040 Sharplaser Ref K912792

Sharplan CO2 Surgical Laser System Ref K971743

Sharplan Lasers, Inc. Ruby Laser System Ref K961279