FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CO2 SURGICAL LASER SYSTEM XML-10
K Number: K841860
·
Decision Nov 8, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
23
Applicant Total
12
Review Days
188
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Basic Information
- Device Name
- CO2 SURGICAL LASER SYSTEM XML-10
- K Number
- K841860
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4500
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Xanar, Inc.
- Date Received
- May 4, 1984
- Decision Date
- November 8, 1984
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EWG), ordered by most recent decision date.
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LASERMATIC SURGILASER MODEL 5050
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ILLUMINA 55 CO2 LASER SYSTEM
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ILLUMINA 25 CO2 LASER SYSTEM
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MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by Xanar, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861688 | XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 | Oct 3, 1986 | Substantially Equivalent |
| K852436 | AMBULASE | Apr 18, 1986 | Substantially Equivalent |
| K860496 | MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY | Mar 14, 1986 | Substantially Equivalent |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | Jan 24, 1986 | Substantially Equivalent |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | Aug 15, 1985 | Substantially Equivalent |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | Aug 15, 1985 | Substantially Equivalent |
| K850805 | CO 2 SURGICAL LASER SYSTEM MODEL NA-40 | Aug 15, 1985 | Substantially Equivalent |
| K844087 | XANAR MODEL XSE-300 SMOKE EVACULATER | Feb 27, 1985 | Substantially Equivalent |
| K833325 | AMBULASE XAM-15 XANAR SURG. LASER | Jan 26, 1984 | Substantially Equivalent |
| K837224 | UNKNOWN | May 2, 1983 | Substantially Equivalent |