FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
K Number: K902940
·
Decision Oct 3, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
58
Review Days
92
Basic Information
- Device Name
- CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM
- K Number
- K902940
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- TRIMEDYNE, INC.
- Date Received
- July 3, 1990
- Decision Date
- October 3, 1990
- 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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| K002308 | OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A | Dec 20, 2000 | Substantially Equivalent |
| K001676 | OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A | Nov 2, 2000 | Substantially Equivalent |
| K992574 | OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A | Oct 29, 1999 | Substantially Equivalent |
| K992230 | OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP | Jul 12, 1999 | Substantially Equivalent |