FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINI-HALO CO2 LASER SYSTEM
K Number: K843915
·
Decision May 10, 1985
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
87
Review Days
218
Basic Information
- Device Name
- MINI-HALO CO2 LASER SYSTEM
- K Number
- K843915
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- COOPERVISION, INC.
- Date Received
- October 4, 1984
- Decision Date
- May 10, 1985
- 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.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by COOPERVISION, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | Dec 23, 2013 | Substantially Equivalent |
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent |
| K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | May 30, 2013 | Substantially Equivalent |
| K113759 | AVAIRA (ENFILCON A) CONTACT LENS | Apr 3, 2012 | Substantially Equivalent |
| K113245 | AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL | Dec 2, 2011 | Substantially Equivalent |
| K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC | Dec 2, 2011 | Substantially Equivalent |
| K111966 | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC | Sep 15, 2011 | Substantially Equivalent |
| K110099 | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT | Jun 29, 2011 | Substantially Equivalent |
| K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Jan 5, 2010 | Substantially Equivalent |
| K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | Sep 29, 2008 | Substantially Equivalent |