FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LENSX LASER SYSTEM
K Number: K101626
·
Decision Oct 18, 2010
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
4
Review Days
131
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Basic Information
- Device Name
- LENSX LASER SYSTEM
- K Number
- K101626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lensx Lasers, Inc.
- Date Received
- June 9, 2010
- Decision Date
- October 18, 2010
- Product Code
- OOE
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | FDA class 2 | Ophthalmic |
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