Medical Mixture-Laser Gas Mixtures
by Standard Welders Supply Co.
510(k) K952162
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952162 | Date1 Jun 1995 | 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- Withdrawn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 Medical Mixture-Laser Gas Mixtures are specialized gas blends designed for use with powered laser surgical instruments. These mixtures are formulated to enhance laser performance in medical procedures, ensuring optimal energy delivery for applications in general and plastic surgery.
Supplied as non-sterile, non-single-use gas mixtures, these products are regulated under FDA 510(k) clearance K952162 with a product code of GEX. They are intended for use in clinical settings where laser-based surgical techniques are applied, adhering to regulatory standards for powered laser surgical instruments as classified under 878.4810.
Other devices from Standard Welders Supply Co.
Questions
AI-generated answers, 1 Oct 2026
What are the Medical Mixture-Laser Gas Mixtures used for?
These gas mixtures are specifically formulated to improve laser performance in powered surgical instruments. They ensure optimal energy delivery during medical procedures, particularly in general and plastic surgery, where precise laser techniques are required. The blends are designed to work with FDA-regulated laser devices classified under 878.4810, ensuring compatibility and safety in clinical settings.
Are the Medical Mixture-Laser Gas Mixtures sterile or single-use?
The Medical Mixture-Laser Gas Mixtures are supplied in a non-sterile form and are intended for reuse. Since they are not single-use, they must be handled and stored according to manufacturer guidelines to maintain their integrity and performance for repeated clinical applications. Always follow proper gas handling protocols to ensure safety and efficacy.
What regulatory approval does this product hold?
This product holds FDA 510(k) clearance under the reference number K952162. The clearance is based on a substantial equivalence determination, meaning it has been evaluated as comparable to a legally marketed predicate device. The product code assigned is GEX, which categorizes it under gas mixtures for medical use.
How should these gas mixtures be stored?
While the specific storage instructions are not detailed in the provided data, gas mixtures like these typically require storage in a cool, dry place, away from direct sunlight and sources of ignition. Ensure the containers are tightly sealed and stored upright to prevent leaks or contamination. Always refer to the manufacturer’s instructions for precise storage guidelines to maintain product integrity.
Are there different models or sizes available for these gas mixtures?
The provided data does not specify varying models or sizes for the Medical Mixture-Laser Gas Mixtures. However, gas mixtures are generally supplied in standardized cylinders or containers based on clinical needs. For exact specifications, such as cylinder sizes or mixture compositions, consult the manufacturer’s documentation or contact Standard Welders Supply Co. directly.