GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
FDA 510(k) clearance K253822 · decided 2026-03-27
Clearance details
- K-number
- K253822
- Device name
- GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
- Applicant
- Zhuhai Fitlens Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-11-28
- Decision date
- 2026-03-27
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- HQD
- Device class
- 2
- Regulation number
- 886.5916
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Zhuhai, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Zhuhai Fitlens Medical Technology Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.