Omnipulse-Max Holmium Laser
FDA 510(k) K951562 · Trimedyne, Inc.
510(k) numberK951562
Submission
- Device name
- Omnipulse-Max Holmium Laser
- Applicant
- Trimedyne, Inc.
Irvine, CA, US - Received
- April 4, 1995
- Decision date
- July 21, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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|---|---|---|---|
| K262426 | Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)GEX · Traditional | Wuhan Pioon Technology Co., Ltd. | 09/10/2026SE |
| K261562 | Diode Laser Therapy SystemGEX · Traditional | Sanhe LEFIS Electronics Co., Ltd. | 09/10/2026SE |
| K261589 | 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 09/02/2026SE |
| K262269 | CO2 Laser System (MBT- CO2 Laser)GEX · Traditional | Beijing Mega Beauty Technology Co., Ltd. | 09/01/2026SE |
| K261821 | 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)GEX · Traditional | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 08/27/2026SE |
| K262070 | Diode Laser Therapy Systems (DL612A)GEX · Traditional | Hebei Zollvan Medical Technology Co., Ltd. | 08/19/2026SE |
| K261964 | Echolaser X4GEX · Traditional | Elesta S.P.A | 08/19/2026SE |
| K261841 | Q Switched Nd:YAG Laser machine (QLQW-01)GEX · Traditional | Beijing Nubway S&T Co., Ltd. | 08/11/2026SE |
| K261221 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed…GEX · Traditional | Olympus Surgical Technologies America | 07/24/2026SE |
| K261738 | Medical Thulium Fiber Laser Systems (UroFiber 150Q)GEX · Traditional | Rhein Laser Technologies Co., Ltd. | 07/21/2026SE |
More from Rhein Laser Technologies Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K053457 | Vapormax IIGEX · Traditional | 12/21/2005SE |
| K050412 | VapormaxGEX · Traditional | 03/14/2005SE |
| K043012 | Omnipulse Mini, Model 2120GEX · Traditional | 11/17/2004SE |
| K041660 | Trimedyne Holmium Laser SystemsGEX · Traditional | 09/08/2004SE |
| K022655 | Trimedyne Side Firing Needle with Vent SheathGEX · Traditional | 11/07/2002SE |
| K013974 | Rmnipulse Holmium Laser SYSTEM/1210; MAX/1210-VHP; Jr. 1230-30; N/A 1500-AGEX · Traditional | 09/23/2002SE |
| K002308 | Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model…GEX · Traditional | 12/20/2000SE |
| K001676 | Omnipulse Holmium Laser System, Omnipulse-Max Holmium Laser System, Model 1210…GEX · Traditional | 11/02/2000SE |
| K992574 | Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models…GEX · Traditional | 10/29/1999SE |
| K992230 | Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HPGEX · Traditional | 07/12/1999SE |
Questions and answers
When was Omnipulse-Max Holmium Laser cleared by the FDA?
Omnipulse-Max Holmium Laser (K951562) received a 510(k) decision of Substantially Equivalent on July 21, 1995, 108 days after the submission was received.
What is the product code of K951562?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.