Tecnol Laser Surgical Mask
by Tecnol New Jersey Wound Care, Inc.
510(k) K874894
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874894 | Date28 Mar 1988 | 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- Withdrawn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
- FXX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Tecnol Laser Surgical Mask is a protective device designed to shield surgical personnel and patients from laser beam exposure during laser surgical procedures. It is classified as a surgical mask with laser-specific protective properties, intended to prevent eye and skin damage from scattered or stray laser radiation.
This device is supplied as a single-use item and is regulated under FDA 510(k) clearance (K874894) with a product code of FXX. It is intended for use in operating rooms or laser treatment settings, adhering to regulatory standards for laser safety. The mask is not reusable and must be discarded after a single procedure to ensure sterility and effectiveness. No additional sterility or MRI safety information is provided in the specifications.