FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASEGUIDE CAT # CLF-600D & CLF-1000D
K Number: K901786
·
Decision Jun 27, 1990
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
12
Review Days
70
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Basic Information
- Device Name
- LASEGUIDE CAT # CLF-600D & CLF-1000D
- K Number
- K901786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Laser Peripherals, LLC
- Date Received
- April 18, 1990
- Decision Date
- June 27, 1990
- 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 | ||
|---|---|---|---|
| K170366 | Laser Peripherals, LLC Family of Bare Laser Fibers | Jun 8, 2017 | Substantially Equivalent |
| K030959 | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 | Apr 25, 2003 | Substantially Equivalent |
| K011207 | LASER PERIPHERALS REUSABLE HOLMIUM FIBER | Jul 24, 2001 | Substantially Equivalent |
| K992083 | SCATTERFREE LATERAL EMITTING FIBER | Jul 12, 1999 | 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 |
| 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 |