FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
K Number: K082871
·
Decision Jul 9, 2009
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
62
Applicant Total
3
Review Days
283
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Basic Information
- Device Name
- XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
- K Number
- K082871
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sis Ltd., Surgical Instrument Systems
- Date Received
- September 29, 2008
- Decision Date
- July 9, 2009
- Product Code
- MSS
- 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 |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | FDA class 1 | Ophthalmic |
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