Laserscope Omniplus Photosurgical Syst/Nd:Yag Otol
FDA 510(k) K855146 · Laserscope
510(k) numberK855146
Submission
- Device name
- Laserscope Omniplus Photosurgical Syst/Nd:Yag Otol
- Applicant
- Laserscope
Santa Clara, CA, US - Received
- December 24, 1985
- Decision date
- April 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LMS – Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4490
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LMS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K871424 | Endocoagulator Model 5, 8 & 20 Argon LaserLMS · Traditional | Hgm, Inc. | 07/08/1987SE |
More from Hgm, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062719 | Greenlight HPS Series Surgical Laser System & AccessoriesGEX · Traditional | 12/01/2006SE |
| K061646 | Laserscope Guided Delivery Device (GDD) Cystourethroscope & AccessoriesFBO · Traditional | 06/27/2006SE |
| K034011 | Gemini Surgical Laser System & AccessoriesGEX · Traditional | 03/30/2004SE |
| K024206 | Aura Isurgical Laser System & AccessoriesGEX · Traditional | 11/17/2003SE |
| K020021 | Lyra Surgical Laser System and Accessiories (Nd:Yag Configuration)GEX · Traditional | 07/02/2002SE |
| K010834 | Lyra Series Surgical Laser System & AccessoriesGEX · Traditional | 05/21/2001SE |
| K010284 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 05/01/2001SE |
| K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched Nd:Yag Configuration)GEX · Traditional | 03/06/2001SE |
| K003147 | Lyra Series Surgical Laser System (SL Series, Nd:Yag Configuration)GEX · Traditional | 12/15/2000SE |
| K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched Nd:Yag Configuration)GEX · Traditional | 03/08/2000SE |
Questions and answers
When was Laserscope Omniplus Photosurgical Syst/Nd:Yag Otol cleared by the FDA?
Laserscope Omniplus Photosurgical Syst/Nd:Yag Otol (K855146) received a 510(k) decision of Substantially Equivalent on April 11, 1986, 108 days after the submission was received.
What is the product code of K855146?
The FDA product code is LMS – Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology, a Class II (moderate risk) device regulated under 21 CFR 874.4490.