HDE
H040002: INTACS PRESCRIPTION INSERTS FOR KERATOCONUS
FDA Humanitarian Device Exemption · ADDITION TECHNOLOGY
Key facts
| HDE number | H040002 |
|---|---|
| Trade name | INTACS PRESCRIPTION INSERTS FOR KERATOCONUS |
| Generic name | Implant, corneal, refractive |
| Applicant | ADDITION TECHNOLOGY |
| Owner/operator | Addition Technology |
| Product code | LQE |
| Approval date | Jul 26, 2004 |
| Docket number | 06M-0233 |
| Notice date | Jun 9, 2006 |
| Establishment registration | 2953726 |
| FEI number | 3000309468 |
At a glance
- 1–9 Supplements
- May 2, 2025 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: