FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
OPUS 10 DENTAL DIODE LASER
K Number: K000990
·
Decision Jun 23, 2000
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
5
Review Days
87
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Basic Information
- Device Name
- OPUS 10 DENTAL DIODE LASER
- K Number
- K000990
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Opusdent , Ltd.
- Date Received
- March 28, 2000
- Decision Date
- June 23, 2000
- 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 Opusdent , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K021508 | OPUSDUO EC DENTAL LASER SYSTEM | Aug 7, 2002 | Substantially Equivalent |
| K014100 | OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND | Jan 8, 2002 | Substantially Equivalent |
| K011769 | OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND | Aug 30, 2001 | Substantially Equivalent |
| K002899 | OPUS 20, MODEL 1ST | Dec 12, 2000 | Substantially Equivalent |