Model 8-B with OS-1 Attachment (C02 Laser for ENT)
FDA 510(k) K862150 · Directed Energy, Inc.
510(k) numberK862150
Submission
- Device name
- Model 8-B with OS-1 Attachment (C02 Laser for ENT)
- Applicant
- Directed Energy, Inc.
Los Angeles, CA, US - Received
- June 4, 1986
- Decision date
- September 4, 1986
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
|---|---|---|
| K904930 | Surgical Carbon Dioxide Laser Syst Model 20-CHGEX · Traditional | 03/21/1991SE |
| K894241 | Model 20-CH W/ AR-10A/U Optical AttachmentGEX · Traditional | 06/18/1990SE |
| K883738 | Carbon Dioxide Laser System Model 20-CX W/Attach.GEX · Traditional | 11/15/1988SE |
| K882926 | Model AU-1 Accessory UnitGEX · Traditional | 09/09/1988SE |
| K880216 | Model 20C W/An AR-10A/U & RL-20A/U for Arthroscop.GEX · Traditional | 03/04/1988SE |
| K873331 | Ortho. Gas Insufflator Model IN-2 for Arthro. SurgHRX · Traditional | 02/17/1988SE |
| K872709 | Model 20-C, RL-20A/U, OB-10A/UHHR · Traditional | 02/02/1988SE |
| K870841 | Model 20-C W/BR-20A/U Attach/Model HL-3.0 OB/GYNHHR · Traditional | 02/02/1988SE |
| K872711 | Model 20-C W/AR-10A/U Attach. for Arthro. SurgeryGEX · Traditional | 09/28/1987SE |
| K872710 | Model 20-B W/OB-10A/U Attach. for Ear, Nose/ThroatEWG · Traditional | 09/24/1987SE |
Questions and answers
When was Model 8-B with OS-1 Attachment (C02 Laser for ENT) cleared by the FDA?
Model 8-B with OS-1 Attachment (C02 Laser for ENT) (K862150) received a 510(k) decision of Substantially Equivalent for Some Indications on September 4, 1986, 92 days after the submission was received.
What is the product code of K862150?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.