DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
FDA 510(k) clearance K123431 · decided 2013-06-17
Clearance details
- K-number
- K123431
- Device name
- DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
- Applicant
- Dreamcon Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-07
- Decision date
- 2013-06-17
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- LPL
- Device class
- 2
- Regulation number
- 886.5925
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mission Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.