The following data is part of a premarket notification filed by Colorsoft Laboratories Corp. with the FDA for Colorsoft Prosthetic Tinted Soft Contact Lens.
| Device ID | K992339 |
| 510k Number | K992339 |
| Device Name: | COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COLORSOFT LABORATORIES CORP. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing COLORSOFT LABORATORIES CORP. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-13 |
| Decision Date | 1999-08-16 |
| Summary: | summary |