FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLARIS DIODE LASER SYSTEM AND ACCESSORIES
K Number: K990914
·
Decision Jul 30, 1999
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
26
Review Days
134
Basic Information
- Device Name
- POLARIS DIODE LASER SYSTEM AND ACCESSORIES
- K Number
- K990914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- XINTEC CORPORATION
- Date Received
- March 18, 1999
- Decision Date
- July 30, 1999
- 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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|---|---|---|---|
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| K951876 | PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES | Mar 25, 1996 | Substantially Equivalent |
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| K951760 | OPTILITE VIII LASER SURGERY ACCESSORIES | Nov 29, 1995 | Substantially Equivalent |
| K945181 | GENERA 100 SURGICAL SYSTEM | Jan 20, 1995 | Substantially Equivalent |