FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRALINE II STERILE DISPOSABLE FIBER
K Number: K933245
·
Decision Apr 21, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
38
Review Days
293
Basic Information
- Device Name
- ULTRALINE II STERILE DISPOSABLE FIBER
- K Number
- K933245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- HERAEUS LASERSONICS, INC.
- Date Received
- July 2, 1993
- Decision Date
- April 21, 1994
- 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 HERAEUS LASERSONICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K923896 | HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS | Nov 25, 1992 | Substantially Equivalent |
| K921807 | ULTRALINE STERILE DISPOSABLE FIBER | Jun 18, 1992 | Substantially Equivalent |
| K915578 | ND;YAG SURGICAL LASER SYSTEMS | Jun 15, 1992 | Substantially Equivalent |
| K915583 | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. | Mar 27, 1992 | Substantially Equivalent |
| K912618 | LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY | Feb 27, 1992 | Substantially Equivalent |
| K913887 | C02 LASER WAVEGUIDE | Dec 9, 1991 | Substantially Equivalent |
| K910530 | CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY | Oct 31, 1991 | Substantially Equivalent |
| K913918 | HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER | Sep 25, 1991 | Substantially Equivalent |
| K913564 | HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE | Sep 16, 1991 | Substantially Equivalent |
| K913513 | LATERALASE STERILE DISPOSABLE FIBER | Sep 11, 1991 | Substantially Equivalent |