Laseguide Cat # CLF-600D & CLF-1000D
FDA 510(k) K901786 · Laser Peripherals, LLC
510(k) numberK901786
Submission
- Device name
- Laseguide Cat # CLF-600D & CLF-1000D
- Applicant
- Laser Peripherals, LLC
Hingham, MA, US - Received
- April 18, 1990
- Decision date
- June 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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…
Other 510(k)s with product code GEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser FibersGEX · Traditional | 06/08/2017SE |
| K030959 | Bare Laser Fiber Models DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100GEX · Special | 04/25/2003SE |
| K011207 | Laser Peripherals Reusable Holmium FiberGEX · Traditional | 07/24/2001SE |
| K992083 | Scatterfree Lateral Emitting FiberGEX · Special | 07/12/1999SE |
| K974229 | LS-905 Fiberchoice Adapter SystemGEX · Traditional | 02/10/1998SE |
| K972272 | Laser Peripherals Holmium Bare FibersGEX · Traditional | 07/29/1997SE |
| K961516 | Laser Peripherals Inc. Bare FiberGEX · Traditional | 06/27/1996SE |
| K961079 | Laser Peripherals Inc. Scatterfree FiberGEX · Traditional | 05/22/1996SE |
| K880591 | Laseguide 600A, 600B, 400A, 400B for Ob-Gyn UseHHR · Traditional | 06/01/1988SE |
| K880592 | Laseguide 600A, 600B, 400A, 400B for Pulmonary UseLLO · Traditional | 04/25/1988SE |
Questions and answers
When was Laseguide Cat # CLF-600D & CLF-1000D cleared by the FDA?
Laseguide Cat # CLF-600D & CLF-1000D (K901786) received a 510(k) decision of Substantially Equivalent on June 27, 1990, 70 days after the submission was received.
What is the product code of K901786?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.