FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
K Number: K855146
·
Decision Apr 11, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
60
Review Days
108
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Basic Information
- Device Name
- LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL
- K Number
- K855146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4490
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Laserscope
- Date Received
- December 24, 1985
- Decision Date
- April 11, 1986
- Product Code
- LMS
- 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 |
|---|---|---|---|
| LMS | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LMS), ordered by most recent decision date.
View allOther 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 |