The following data is part of a premarket notification filed by Geo Medical Co., Ltd. with the FDA for Geo Magic Color (polymacon) Soft (hydrophilic) Contact Lens.
| Device ID | K110835 |
| 510k Number | K110835 |
| Device Name: | GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | GEO MEDICAL CO., LTD. 27001 LA PAZ ROAD SUITE 312 Mission Viejo, CA 92691 |
| Contact | Albert Rego |
| Correspondent | Albert Rego GEO MEDICAL CO., LTD. 27001 LA PAZ ROAD SUITE 312 Mission Viejo, CA 92691 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-25 |
| Decision Date | 2012-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800071352709 | K110835 | 000 |
| 08800071352693 | K110835 | 000 |
| 08800071352686 | K110835 | 000 |
| 08800071352679 | K110835 | 000 |