BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
FDA 510(k) clearance K101122 · decided 2010-08-09
Clearance details
- K-number
- K101122
- Device name
- BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
- Applicant
- Benz Research and Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-21
- Decision date
- 2010-08-09
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sarasota, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.