The following data is part of a premarket notification filed by Interojo Inc. with the FDA for Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens For Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K153766 |
| 510k Number | K153766 |
| Device Name: | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens For Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens For Daily Wear |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Interojo Inc. 28 & 25 Sandan-Ro 15beon-Gil Pyongtaek-city, KR 459040 |
| Contact | Si-chul Rho |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-30 |
| Decision Date | 2016-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806392000770 | K153766 | 000 |
| 08806392040080 | K153766 | 000 |