# K981196: Meditec Link

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap-Meditec North America
- Decided: Jun 17, 1998 after 90 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Infinitech Multi-Spot Slit Lamp laser Adapter: named in the summary without a submission number

## Indications for use
The Meditec Link is intended to be attached to slit lamps to allow green laser energy light to be delivered to the slit lamp via fiber optic. Once the Meditec Link is attached to a slit lamp the user should refer to the User's Manual or Operator's Manual provided with the laser for clinical use information regarding the laser and for additional use instructions or information. The Meditec Link is presently designed for attachment to Zeiss Slit Lamps or to Haag Streit 900 BQ and 900 BM Slit Lamps.

Source page: https://510kreport.com/device/K981196
Methodology: https://510kreport.com/methodology