FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
K Number: K060372
·
Decision Aug 16, 2006
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
9
Review Days
184
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Basic Information
- Device Name
- INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
- K Number
- K060372
- 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
- Intra Lase Corp.
- Date Received
- February 13, 2006
- Decision Date
- August 16, 2006
- 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 Intra Lase Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K073404 | IFS LASER SYSTEM | Apr 25, 2008 | Substantially Equivalent |
| K063682 | INTRALASE FUSION LASER | Feb 9, 2007 | Substantially Equivalent |
| K041893 | INTRALASE FS LASER | Jul 29, 2005 | Substantially Equivalent |
| K031960 | INTRALASE FS LASER | Sep 29, 2003 | Substantially Equivalent |
| K013941 | PULSION FS LASER KERATOME | Feb 27, 2002 | Substantially Equivalent |
| K002890 | INTRALASE 600C LASER KERATOME | Aug 9, 2001 | Substantially Equivalent |
| K001211 | MODIFICATION TO INTRALASE 600C LASER KERATOME | Dec 4, 2000 | Substantially Equivalent |
| K993153 | INTRALASE 600C LASER KERATOME | Dec 17, 1999 | Substantially Equivalent |