Sharplan Model 712 Acuspot Micromanipulator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K951204 ↗

FDA Product Code

GEX

Device Class

Class II

Regulation

21 CFR Part 878.4810

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sharplan Model 1050 Sealed-Off CO2 Surgical Laser

  Class II

  FDA 510(k) K890287 Active Cleared 12 Apr 1989

• Sharplan Model 1080S CO2 Surgical Laser

  Class II

  FDA 510(k) K933918 Active Cleared 25 Aug 1994

• Sharplan Model 750 Remote Control Unit (Rcu)

  Class II

  FDA 510(k) K890286 Active Cleared 5 Apr 1989

• Sharplan Nd:yag Lasers for ENT and Neck Surgery

  Class II

  FDA 510(k) K900345 Active Cleared 10 Apr 1990

• Sharplan CO2 Surg. Laser, Mo. 1039 Surgicenter 40

  Class II

  FDA 510(k) K921146 Active Cleared 8 Jun 1992

• Sharplan Nd:yag Surgical Laser, Model 3060 Sharplaser 60

  Class II

  FDA 510(k) K926543 Active Cleared 9 Mar 1994

See all devices from Sharplan Lasers, Inc. →

• What is the Sharplan Model 712 Acuspot Micromanipulator used for?

  The Sharplan Model 712 Acuspot Micromanipulator is designed for precise free-beam laser microsurgery, specifically coupling with surgical microscopes to deliver targeted tissue interaction using a CO₂ laser. Its 160-micron laser spot size and adjustable working distances (200–400 mm) make it ideal for specialized procedures in ENT (ear, nose, and throat) and gynecology, where fine control and accuracy are critical.

• How is the Sharplan Model 712 Acuspot Micromanipulator supplied and maintained?

  This device is supplied as a reusable medical instrument, meaning it is intended for repeated use in clinical settings. Proper sterilization and maintenance are required to ensure functionality and safety, following the manufacturer’s guidelines. Storage should adhere to sterile instrument protocols to preserve its performance for future procedures.

• Can the Sharplan Model 712 Acuspot Micromanipulator be used with MRI equipment?

  No, the Sharplan Model 712 Acuspot Micromanipulator is explicitly not indicated for use in MRI environments. Its design and materials are optimized for traditional surgical settings, and compatibility with MRI systems is not supported or tested by the manufacturer.

• What working distances and adjustments are available with this micromanipulator?

  The device features an adjustable design with variable working distances ranging from 200 mm to 400 mm, allowing clinicians to accommodate different surgical setups and microscope configurations. This flexibility ensures adaptability for diverse procedural needs in specialized fields like ENT and gynecology.

• What regulatory clearance does the Sharplan Model 712 Acuspot Micromanipulator hold?

  The device holds FDA 510(k) clearance (K951204), classified as substantially equivalent to prior generations under the General, Plastic Surgery advisory committee. This clearance confirms its compliance with U.S. regulatory standards for laser surgical accessories, though it does not imply approval for all clinical applications beyond its intended use.