FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
K Number: K030181
·
Decision Apr 17, 2003
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
11
Review Days
90
Basic Information
- Device Name
- INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
- K Number
- K030181
- 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
- INTERNATIONAL BIOPHYSICS CORP.
- Date Received
- January 17, 2003
- Decision Date
- April 17, 2003
- 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 INTERNATIONAL BIOPHYSICS CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K072688 | LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 | Jan 11, 2008 | Substantially Equivalent |
| K992657 | IBC VRV, MODEL 1350 | Feb 18, 2000 | Substantially Equivalent |
| K992785 | IBC FLOGUARD, MODEL 6050 | Jan 14, 2000 | Substantially Equivalent |
| K992964 | IBC VENT VALVE, MODEL 1400 | Nov 19, 1999 | Substantially Equivalent |
| K983272 | IBC FLOPUMP, MODEL 6000 | Mar 24, 1999 | Substantially Equivalent |
| K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) | Apr 8, 1998 | Substantially Equivalent |
| K963756 | IBC CARDIAC SUCTION WARD | Nov 14, 1997 | Substantially Equivalent |
| K963698 | CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4 | Mar 20, 1997 | Substantially Equivalent |
| K955380 | IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4) | May 14, 1996 | Substantially Equivalent |
| K955379 | IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4) | May 14, 1996 | Substantially Equivalent |