Hyperion LTK System
PMA P990078
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP990078 | Date30 Jun 2000 | 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- Withdrawn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
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- PMA Number
- FDA Product Code
- LOI
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Hyperion LTK System is a laser, neodymium:Yag, ophthalmic device for uses other than posterior capsulotomy & cutting pupillary. It is indicated for the temporary reduction of hyperopia in patients with +0.75 to +2.5 diopters of manifest refraction spherical equivalent at the spectacle plane, with cylinder less than or equal to +-0.75 diopters, who are 40 years of age or older with documented stability of refraction for the prior 6 months.
The device is supplied by Sunrise Technologies, Inc., located in Fremont, CA. It received FDA PMA approval (P990078) on June 30, 2000, and is classified as a Class III device under product code LOI. No information is provided regarding sterility, single-use status, MRI safety, sizes, or storage conditions.
Other devices from Sunrise Technologies, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Hyperion LTK System indicated for?
The Hyperion LTK System is indicated for the temporary reduction of hyperopia in patients with +0.75 to +2.5 diopters of manifest refraction spherical equivalent at the spectacle plane, with cylinder less than or equal to +-0.75 diopters, who are 40 years of age or older and have demonstrated stability of refraction for the prior 6 months, as defined by a change of less than or equal to 0.50D in spherical and cylindrical components.
Who manufactures the Hyperion LTK System and where are they located?
The Hyperion LTK System is manufactured by Sunrise Technologies, Inc., located at 3400 W. Warren Ave., Fremont, CA 94538.
What regulatory authorization does the Hyperion LTK System have?
The Hyperion LTK System has FDA PMA approval, with PMA number P990078, and was approved on June 30, 2000, following receipt of the application on November 3, 1999.