FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K Number: K862005
·
Decision Aug 29, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
23
Applicant Total
60
Review Days
94
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Basic Information
- Device Name
- LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
- K Number
- K862005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4500
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Laserscope
- Date Received
- May 27, 1986
- Decision Date
- August 29, 1986
- Product Code
- EWG
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| EWG | Laser, Ent Microsurgical Carbon-Dioxide | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Laserscope
| K Number | Device Name | ||
|---|---|---|---|
| K062719 | GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES | Dec 1, 2006 | Substantially Equivalent |
| K061646 | LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES | Jun 27, 2006 | Substantially Equivalent |
| K034011 | GEMINI SURGICAL LASER SYSTEM & ACCESSORIES | Mar 30, 2004 | Substantially Equivalent |
| K024206 | AURA ISURGICAL LASER SYSTEM & ACCESSORIES | Nov 17, 2003 | Substantially Equivalent |
| K020021 | LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION) | Jul 2, 2002 | Substantially Equivalent |
| K010834 | LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES | May 21, 2001 | Substantially Equivalent |
| K010284 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | May 1, 2001 | Substantially Equivalent |
| K003765 | LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION) | Mar 6, 2001 | Substantially Equivalent |
| K003147 | LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION) | Dec 15, 2000 | Substantially Equivalent |
| K990718 | ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) | Mar 8, 2000 | Substantially Equivalent |