Illumina 40 CO2 Laser System
FDA 510(k) K880427 · Cooper Lasersonics, Inc.
510(k) numberK880427
Submission
- Device name
- Illumina 40 CO2 Laser System
- Applicant
- Cooper Lasersonics, Inc.
Santa Clara, CA, US - Received
- February 1, 1988
- Decision date
- April 18, 1988
- 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 |
| 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 |
| K862150 | Model 8-B with OS-1 Attachment (C02 Laser for ENT)EWG · Traditional | Directed Energy, Inc. | 09/04/1986SN |
More from Directed Energy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880809 | Illumina Model 55 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880808 | Illumina Model 40 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880807 | Illumina Model 25 CO2 Laser for General/Plastic SuGEX · Traditional | 04/18/1988SE |
| K880429 | Illumina 55 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880428 | Illumina 25 CO2 Laser SystemEWG · Traditional | 04/18/1988SE |
| K880171 | Model 4900 Nd:Yag Laser for Gastro & Genitour ApplLNK · Traditional | 04/11/1988SE |
| K880173 | Model 4900 Nd:Yag Laser for Endometrial AblationHHR · Traditional | 03/24/1988SE |
| K880170 | Model 4900 Nd:Yag Laser for Pulmonary ObstructionsLLO · Traditional | 03/24/1988SE |
| K880172 | Model 4900 Nd:Yag Laser for Neurosurgery Applica.LKW · Traditional | 03/11/1988SE |
| K875115 | Infraguide(Tm)GEX · Traditional | 02/26/1988SE |
Questions and answers
When was Illumina 40 CO2 Laser System cleared by the FDA?
Illumina 40 CO2 Laser System (K880427) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 77 days after the submission was received.
What is the product code of K880427?
The FDA product code is EWG – Laser, Ent Microsurgical Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 874.4500.