FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCATTERFREE LATERAL EMITTING FIBER
K Number: K992083
·
Decision Jul 12, 1999
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
21
Basic Information
- Device Name
- SCATTERFREE LATERAL EMITTING FIBER
- K Number
- K992083
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- LASER PERIPHERALS LLC.
- Date Received
- June 21, 1999
- Decision Date
- July 12, 1999
- 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 LASER PERIPHERALS LLC.
| K Number | Device Name | ||
|---|---|---|---|
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | Apr 25, 2003 | Substantially Equivalent |
| K974229 | LS-905 FIBERCHOICE ADAPTER SYSTEM | Feb 10, 1998 | Substantially Equivalent |
| K972272 | LASER PERIPHERALS HOLMIUM BARE FIBERS | Jul 29, 1997 | Substantially Equivalent |
| K961516 | LASER PERIPHERALS INC. BARE FIBER | Jun 27, 1996 | Substantially Equivalent |
| K961079 | LASER PERIPHERALS INC. SCATTERFREE FIBER | May 22, 1996 | Substantially Equivalent |
| K901786 | LASEGUIDE CAT # CLF-600D & CLF-1000D | Jun 27, 1990 | Substantially Equivalent |
| K880591 | LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE | Jun 1, 1988 | Substantially Equivalent |
| K880592 | LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE | Apr 25, 1988 | Substantially Equivalent |
| K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B | Mar 23, 1988 | Substantially Equivalent |