Laser Lens-Various Models
510(k) K834610
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834610 | Date5 Apr 1984 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- HQF
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4390
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Laser Lens-Various Models is an ophthalmic laser device. It is classified as a Class II medical device under regulation number 886.4390.
The device received FDA 510(k) clearance (K834610) on April 5, 1984, following a traditional review process. It is manufactured by Meditec of America and assigned product code HQF.
Other devices from Meditec of America
Questions
AI-generated answers, 1 Oct 2026
What is the Laser Lens-Various Models device used for?
The Laser Lens-Various Models is an ophthalmic laser device intended for use in eye procedures requiring laser delivery through a lens system, as indicated by its classification under regulation 886.4390 and product code HQF for ophthalmic applications.
How was the Laser Lens-Various Models device cleared for market?
The device received FDA 510(k) clearance through a traditional review process, with clearance granted on April 5, 1984, under K834610, demonstrating substantial equivalence to a legally marketed predicate device.
Who manufactures the Laser Lens-Various Models device and where is it located?
The Laser Lens-Various Models is manufactured by Meditec of America, located at 4221 Richmond Rd., NW, Walker, MI 49534, United States, as specified in the device’s registration and mailing address fields.