FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU
K Number: K880809
·
Decision Apr 18, 1988
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
54
Review Days
52
Basic Information
- Device Name
- ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU
- K Number
- K880809
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- COOPER LASERSONICS, INC.
- Date Received
- February 26, 1988
- Decision Date
- April 18, 1988
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by COOPER LASERSONICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K880807 | ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880429 | ILLUMINA 55 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880808 | ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU | Apr 18, 1988 | Substantially Equivalent |
| K880427 | ILLUMINA 40 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880428 | ILLUMINA 25 CO2 LASER SYSTEM | Apr 18, 1988 | Substantially Equivalent |
| K880171 | MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL | Apr 11, 1988 | Substantially Equivalent |
| K880173 | MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION | Mar 24, 1988 | Substantially Equivalent |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Mar 24, 1988 | Substantially Equivalent |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | Mar 11, 1988 | Substantially Equivalent |
| K875115 | INFRAGUIDE(TM) | Feb 26, 1988 | Substantially Equivalent |