Model 545-45 Laser for Ear, Nose & Throat
FDA 510(k) K860975 · Britt Corp., Inc.
510(k) numberK860975
Submission
- Device name
- Model 545-45 Laser for Ear, Nose & Throat
- Applicant
- Britt Corp., Inc.
Los Angeles, CA, US - Received
- March 14, 1986
- Decision date
- July 18, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EWG – Laser, Ent Microsurgical Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4500
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EWG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924652 | Benson CCA100EWG · Traditional | Benson Medical Instruments Co. | 04/09/1993SE |
| K870587 | Lasermatic Surgilaser Model 5050EWG · Traditional | Lasermatic OY | 08/10/1988SN |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K880427 | Illumina 40 CO2 Laser SystemEWG · Traditional | Cooper Lasersonics, Inc. | 04/18/1988SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | Directed Energy, Inc. | 09/24/1987SE |
| K870840 | Model 20-C W/BR-20A/U Attach/Model HL-3.O AttachEWG · Traditional | Directed Energy, Inc. | 06/12/1987SE |
| K864975 | Laserscope Omniplus Photosurgical System for (ENT)EWG · Traditional | Laserscope | 02/25/1987SE |
| K862866 | Model 10-C W/LP-10A/U & OS-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
| K862865 | Model 10-C W/LP-10A/U & OB-10A/U for Oral/Ent UseEWG · Traditional | Directed Energy, Inc. | 01/09/1987SE |
More from Directed Energy, Inc.
| 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 |
| 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 |
| K860278 | Model 525-25 Watt CO2 Laser for Derma/PlasticGEX · Traditional | 04/15/1986SE |
| K851425 | Model J25-25 Watt CO2 LaserHHR · Traditional | 11/12/1985SE |
| K840036 | Fitex · Traditional | 10/26/1984SE |
Questions and answers
When was Model 545-45 Laser for Ear, Nose & Throat cleared by the FDA?
Model 545-45 Laser for Ear, Nose & Throat (K860975) received a 510(k) decision of Substantially Equivalent on July 18, 1986, 126 days after the submission was received.
What is the product code of K860975?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.