Endo-Lase CD40 for Otorhinolaryngology
FDA 510(k) K853902 · Endo Lase, Inc.
510(k) numberK853902
Submission
- Device name
- Endo-Lase CD40 for Otorhinolaryngology
- Applicant
- Endo Lase, Inc.
Washington, DC, US - Received
- September 20, 1985
- Decision date
- January 9, 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 |
|---|---|---|
| K853900 | Endo-Lase CD40 for NeurosurgeryGEX · Traditional | 06/18/1986SE |
| K853878 | Endo-Lase CD-100 CO2 Laser for NeurosurgeryGEX · Traditional | 05/02/1986SE |
| 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 |
| K853875 | Endo-Lase CD-100 CO2 Laser for OtorhinolaryngologyEWG · Traditional | 01/09/1986SE |
Questions and answers
When was Endo-Lase CD40 for Otorhinolaryngology cleared by the FDA?
Endo-Lase CD40 for Otorhinolaryngology (K853902) received a 510(k) decision of Substantially Equivalent on January 9, 1986, 111 days after the submission was received.
What is the product code of K853902?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.