FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
K Number: K902263
·
Decision Jul 23, 1990
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
58
Review Days
63
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Basic Information
- Device Name
- OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION
- K Number
- K902263
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.6160
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Trimedyne, Inc.
- Date Received
- May 21, 1990
- Decision Date
- July 23, 1990
- Product Code
- GGX
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GGX | Pipette, Sahli | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGX), ordered by most recent decision date.
View allOther Clearances by Trimedyne, Inc.
| K Number | Device Name | ||
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| K050412 | VAPORMAX | Mar 14, 2005 | Substantially Equivalent |
| K043012 | OMNIPULSE MINI, MODEL 2120 | Nov 17, 2004 | Substantially Equivalent |
| K041660 | TRIMEDYNE HOLMIUM LASER SYSTEMS | Sep 8, 2004 | Substantially Equivalent |
| K022655 | TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH | Nov 7, 2002 | Substantially Equivalent |
| K013974 | RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A | Sep 23, 2002 | Substantially Equivalent |
| 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 |