FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILT ARGON HP
K Number: K964524
·
Decision Mar 18, 1997
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
9
Review Days
126
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Basic Information
- Device Name
- ILT ARGON HP
- K Number
- K964524
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ion Laser Technology
- Date Received
- November 12, 1996
- Decision Date
- March 18, 1997
- Product Code
- EBZ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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Other Clearances by Ion Laser Technology
| K Number | Device Name | ||
|---|---|---|---|
| K974369 | APOLLO 9500 | Jan 6, 1998 | Substantially Equivalent |
| K953898 | ACL-5500 PRECISION CURING UNIT (PCU) | Feb 15, 1996 | Substantially Equivalent |
| K954460 | ILT SURGICAL LASER | Dec 18, 1995 | Substantially Equivalent |
| K950351 | CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) | Mar 24, 1995 | Substantially Equivalent |
| K944317 | GENESIS 2000 | Oct 11, 1994 | Substantially Equivalent |
| K944206 | GENESIS 2000 | Oct 11, 1994 | Substantially Equivalent |
| K915656 | CARBON DIOXIDE CO2 LASER | Apr 10, 1992 | Substantially Equivalent |
| K914726 | ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED | Dec 17, 1991 | Substantially Equivalent |