Endo-Lase CD-100 CO2 Laser for Neurosurgery
FDA 510(k) K853878 · Endo Lase, Inc.
510(k) numberK853878
Submission
- Device name
- Endo-Lase CD-100 CO2 Laser for Neurosurgery
- Applicant
- Endo Lase, Inc.
Washington, DC, US - Received
- September 17, 1985
- Decision date
- May 2, 1986
- 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 |
|---|---|---|
| K853900 | Endo-Lase CD40 for NeurosurgeryGEX · Traditional | 06/18/1986SE |
| K855093 | Medilas 2 Nd:Yag Laser Surgery SystemHHR · Traditional | 02/21/1986SE |
| K853903 | Endo-Lase CD40 CO2 for GynecologyHHR · Traditional | 02/21/1986SE |
| K853876 | Endo-Lse CD-100 CO2 Laser for GynecologyHHR · Traditional | 02/21/1986SE |
| K853901 | Endo-Lase CD 40 for DermatologyGEX · Traditional | 02/19/1986SE |
| K853877 | Endo-Lase CD-100 CO2 Laser for DermatologyGEX · Traditional | 02/19/1986SE |
| K853580 | Medilas 2LKW · Traditional | 02/13/1986SE |
| K860152 | Model 700 Evacuator for Use with Laser SurgeryLNK · Traditional | 02/05/1986SE |
| K853902 | Endo-Lase CD40 for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
| K853875 | Endo-Lase CD-100 CO2 Laser for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
Questions and answers
When was Endo-Lase CD-100 CO2 Laser for Neurosurgery cleared by the FDA?
Endo-Lase CD-100 CO2 Laser for Neurosurgery (K853878) received a 510(k) decision of Substantially Equivalent on May 2, 1986, 227 days after the submission was received.
What is the product code of K853878?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.