FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COPPER VAPOR LASER SYSTEM
K Number: K915370
·
Decision Feb 7, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
13
Review Days
72
Basic Information
- Device Name
- COPPER VAPOR LASER SYSTEM
- K Number
- K915370
- 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
- METATECH CORP.
- Date Received
- November 27, 1991
- Decision Date
- February 7, 1992
- 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 METATECH CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K924314 | MOBILE STANDING FRAME | Feb 12, 1993 | Substantially Equivalent |
| K903883 | VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES | Sep 19, 1990 | Substantially Equivalent |
| K890865 | HEXASCAN SCANNER HANDPIECE | Mar 24, 1989 | Substantially Equivalent |
| K883541 | METALASER VASCULASE | Nov 4, 1988 | Substantially Equivalent |
| K883881 | MODIFIED MODEL 2001 FIBER OPTICS CATHETER | Oct 27, 1988 | Substantially Equivalent |
| K883518 | EVENT MARKER & A SECOND PRESSURE TREND OUTPUT | Sep 22, 1988 | Substantially Equivalent |
| K882552 | METATECH ROBINSON BOLT ACCESSORY | Sep 8, 1988 | Substantially Equivalent |
| K882367 | METATECH MICROCLIP APPLICATOR | Aug 25, 1988 | Substantially Equivalent |
| K882286 | EXPANSION COUPLER & MANUAL DRILL AS ACCESSORY SET | Jul 18, 1988 | Substantially Equivalent |
| K881447 | METATECH METAL MICROCLIP | Jun 22, 1988 | Substantially Equivalent |