Picasso Laser System
510(k) K083142
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083142 | Date13 Mar 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Picasso Laser System is a Dental Diode Laser System (Product Code: GEX) designed for soft tissue procedures. It delivers precise, controlled laser energy for applications such as gingival contouring, frenectomy, and periodontal therapy. Its classification as a substantially equivalent device under FDA 510(k) clearance (K083142) reflects its alignment with established laser-based surgical instruments in plastic surgery and dentistry. The system operates via a diode laser, enabling targeted tissue ablation with minimal thermal damage.
The device is supplied as a reusable medical instrument and is intended for use in dental and soft tissue surgical settings. It requires proper training for operation, as indicated by the manufacturer’s support resources, though no explicit sterility or single-use designation is stated in the regulatory data. The system’s MRI safety is not specified, and no details on storage conditions or additional accessories are provided beyond the core laser unit. Authorisation is granted under FDA 510(k) clearance, with no mention of CE marking or other regulatory approvals.
Other devices from Amd Lasers, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Picasso Laser System used for in dental procedures?
The Picasso Laser System is designed specifically for soft tissue dental applications. It provides controlled laser energy to perform procedures such as gingival contouring, frenectomy (releasing tissue attachments), and periodontal therapy. The diode laser technology ensures targeted tissue ablation with reduced thermal damage, making it suitable for delicate surgical tasks in dentistry.
Is the Picasso Laser System reusable or single-use?
The Picasso Laser System is supplied as a reusable medical instrument. While it is intended for repeated use in clinical settings, proper sterilization protocols must be followed between procedures to maintain safety and efficacy. The manufacturer does not explicitly designate it as single-use, so adherence to standard reusable device protocols is required.
What training or expertise is required to operate the Picasso Laser System?
Operation of the Picasso Laser System requires proper training due to its precision and the nature of laser-based procedures. The manufacturer provides support resources to assist clinicians in understanding safe and effective use. Training ensures accurate application, minimizes risks, and maximizes outcomes for soft tissue treatments.
Are there any specific storage conditions mentioned for the Picasso Laser System?
The regulatory data for the Picasso Laser System does not specify detailed storage conditions beyond standard practices for reusable medical devices. It is recommended to follow manufacturer guidelines for environmental factors like temperature and humidity to preserve the device’s functionality and ensure longevity.
Does the Picasso Laser System have any limitations regarding MRI safety?
The regulatory information for the Picasso Laser System does not provide explicit details about its MRI safety. Clinicians should consult the manufacturer’s instructions or technical documentation to determine compatibility with MRI environments, as laser systems may contain metallic or electronic components that could pose risks in magnetic fields.