Boston Equalens II (Oprifocon A) Contact Lens for Orthokeratology
510(k) K003933
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003933 | Date16 Feb 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy
- 510(k) Number
- FDA Product Code
- MUW
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5916
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Boston Equalens II (Oprifocon A) contact lens for orthokeratology is a gas permeable lens designed for overnight wear. It is made from a fluoro silicone acrylate polymer, hexafocon A, with a water content of less than 1%.
The lens is supplied in various tints, including blue, green, red, and yellow, using D&C colorants. It is a single-use device, and no specific storage or MRI safety information is provided in the data.