FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
K Number: K024061
·
Decision Mar 7, 2003
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
19
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
- K Number
- K024061
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peregrine Surgical , Ltd.
- Date Received
- December 9, 2002
- Decision Date
- March 7, 2003
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Peregrine Surgical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K151604 | 23ga Chandelier Illuminator, 25ga Chandelier Illuminator | Sep 11, 2015 | Substantially Equivalent |
| K132614 | PEREGRINE CURVED ILLUMINATING LASER PROBE | Nov 14, 2013 | Substantially Equivalent |
| K122997 | 23GA CURVED ILLUMINATING LASER PROBE | Jun 26, 2013 | Substantially Equivalent |
| K122905 | PEREGRINE 23GA CURVED LASER PROBE | Apr 30, 2013 | Substantially Equivalent |
| K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | Jun 21, 2006 | Substantially Equivalent |
| K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | Jun 27, 2003 | Substantially Equivalent |
| K990518 | PEREGRINE WET SET, MODEL PD400.00 | Mar 25, 1999 | Substantially Equivalent |
| K981907 | V.F.I.-VISCOUS FLUID INFUSION TUBING SET | Aug 4, 1998 | Substantially Equivalent |
| K980797 | PEREGRINE FIBER OPTIC MULTI-FUNCTION MANIPULATOR | May 19, 1998 | Substantially Equivalent |
| K980530 | PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 | May 12, 1998 | Substantially Equivalent |