Rigid Gas Permeable Contact Lenses
PMA P900001
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900001 | Date14 Jan 1992 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Lens, contact (other material) - daily
- PMA Number
- FDA Product Code
- HQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5916
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S004 (Normal 180 Day Track)
Overview
AI-generated summary, 18 Sep 2026
These are rigid gas permeable contact lenses, a type of ophthalmic device designed for daily wear. They are manufactured from materials that allow oxygen to pass through, promoting corneal health while providing clear, stable vision for extended periods.
Supplied as single-use daily lenses, they are intended for use in ophthalmic settings and are regulated under FDA PMA approval (P900001). The lenses are classified as Class II devices under regulation 886.5916 and must be handled according to sterile contact lens protocols. Multiple product codes (e.g., HQD) and registration numbers identify specific variants, ensuring traceability and compliance with regulatory standards.
Other devices from The Lifestyle Company, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these contact lenses designed for overnight wear or only daily use as part of a regular schedule?
These rigid gas permeable contact lenses are explicitly designed for daily wear only, not for overnight use. The product description emphasizes their suitability for extended periods during waking hours while promoting corneal health through oxygen permeability. Overnight wear would require a different classification and regulatory approval, which is not indicated here.
How should these lenses be stored to maintain sterility and usability?
Since these lenses are classified as sterile and must adhere to sterile contact lens protocols, they should be stored in their original, sealed packaging until use. The packaging is likely designed to preserve sterility, and any opened or exposed lenses should be discarded to prevent contamination. Always follow the manufacturer’s specific storage instructions included with the product.
Are these lenses reusable, or are they intended for single-use only?
These lenses are single-use daily lenses, meaning each lens is intended for one-day wear and should not be reused. The product description explicitly states they are supplied as daily-use items, which aligns with single-use protocols to ensure hygiene and safety for the wearer.
What regulatory pathway was followed for approval of these lenses, and how does that affect their use?
These rigid gas permeable contact lenses were approved under the FDA Premarket Approval (PMA) pathway, specifically under PMA number P900001. This pathway is typically used for devices with higher risk or novel technologies, ensuring rigorous evaluation of safety and effectiveness. Clinicians and users should confirm compliance with FDA guidelines and the manufacturer’s instructions, as PMA approval ensures the device meets stringent regulatory standards for ophthalmic use.
What does the product code (e.g., HQD) indicate about these lenses, and how does it relate to their traceability?
The product code HQD (along with multiple registration numbers) identifies these lenses within the FDA’s classification system for daily-use contact lenses made from other materials (e.g., rigid gas permeable). These codes are used for regulatory traceability, ensuring that each variant of the lens can be tracked for compliance, recalls, or quality control. The presence of these codes confirms the lenses are part of a formally registered product line under FDA oversight.