Zeiss Opmilas 144 Surgical Lasers
510(k) K942439
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK942439 | Date1 Jul 1994 | 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- Withdrawn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, 6 Oct 2026
The Zeiss Opmilas 144 Surgical Lasers are solid-state lasers featuring a pulsed 1.44 μm wavelength produced from a neodymium:YAG crystal using proprietary technology developed by Carl Zeiss. The device includes the Opmilas 144 and Opmilas 144 Plus models and is designed for arthroscopic laser surgery.
The system employs a recirculating water cooling system and features a standard SMA 905 connector on the delivery systems, which threads onto the fiber coupler on the front panel of the laser. It received FDA 510(k) clearance K942439 on July 1, 1994, and is manufactured by Zeiss Humphrey System.
Other devices from Zeiss Humphrey System
Questions
AI-generated answers, 6 Oct 2026
What is the Zeiss Opmilas 144 Surgical Laser used for?
The Zeiss Opmilas 144 Surgical Laser is designed for arthroscopic laser surgery, utilizing a pulsed 1.44 μm wavelength from a neodymium:YAG crystal to perform precise tissue ablation in joint procedures.
How is the Zeiss Opmilas 144 Surgical Laser supplied and what are its key components?
The Zeiss Opmilas 144 Surgical Laser system includes the Opmilas 144 and Opmilas 144 Plus models, features a recirculating water cooling system, and has a standard SMA 905 connector on the delivery system that threads onto the fiber coupler on the laser's front panel.
What regulatory clearance does the Zeiss Opmilas 144 Surgical Laser have?
The Zeiss Opmilas 144 Surgical Laser received FDA 510(k) clearance under K942439 on July 1, 1994, and was determined to be substantially equivalent to a predicate device.