Model 525-25 Watt CO2 Laser for Derma/Plastic
FDA 510(k) K860278 · Britt Corp., Inc.
510(k) numberK860278
Submission
- Device name
- Model 525-25 Watt CO2 Laser for Derma/Plastic
- Applicant
- Britt Corp., Inc.
Hauppague, NY, US - Received
- January 27, 1986
- Decision date
- April 15, 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 |
|---|---|---|
| K003828 | Vaso Press DVT Foot Garment #Vp 520JOW · Traditional | 05/18/2001SE |
| K991038 | Vaso Press DVT System, Models VP500, VP501JOW · Traditional | 06/22/2000SE |
| K974393 | Vaso Press SystemJOW · Traditional | 03/19/1999SE |
| K860977 | Model 545-45 for Neurological Surgical ApplicationLLF · Traditional | 10/16/1986SE |
| K860975 | Model 545-45 Laser for Ear, Nose & ThroatEWG · Traditional | 07/18/1986SE |
| K860974 | Model 545-45 Laser for Derma., Pod., SurgicalGEX · Traditional | 07/07/1986SE |
| K860277 | Model 525-25 Watt C02 Laser for Ear, Nose & ThroatEWG · Traditional | 05/06/1986SE |
| K860273 | Model 525 - 25 Watt CO2 Medical Laser/PodiatryGEX · Traditional | 04/23/1986SE |
| K851425 | Model J25-25 Watt CO2 LaserHHR · Traditional | 11/12/1985SE |
| K840036 | Fitex · Traditional | 10/26/1984SE |
Questions and answers
When was Model 525-25 Watt CO2 Laser for Derma/Plastic cleared by the FDA?
Model 525-25 Watt CO2 Laser for Derma/Plastic (K860278) received a 510(k) decision of Substantially Equivalent on April 15, 1986, 78 days after the submission was received.
What is the product code of K860278?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.