FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PuriLens Plus Preservative Free Saline
K Number: K200747
·
Decision May 15, 2020
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
1
Review Days
53
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Basic Information
- Device Name
- PuriLens Plus Preservative Free Saline
- K Number
- K200747
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5928
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Lifestyle Company, Inc.
- Date Received
- March 23, 2020
- Decision Date
- May 15, 2020
- Product Code
- LPN
- 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 |
|---|---|---|---|
| LPN | Accessories, Soft Lens Products | FDA class 2 | Ophthalmic |
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