# K991592: Ksea DE LA Plaza Blepharoplasty Set

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Nov 2, 1999 after 179 days
- Product code: HNI (Retractor, Ophthalmic)
- Device class: 1
- Regulation: 21 CFR 886.4350
- 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) orbital retractors currently marketed by Padgett Instruments Inc.: named in the summary without a submission number
- (no number) orbital retractors currently marketed by Snowden Pencer: named in the summary without a submission number

## Indications for use
These instruments are manually operated surgical devices intended to for use in plastic-aesthetic operations of the orbital region, including bleparoplasty procedures.

Source page: https://510kreport.com/device/K991592
Methodology: https://510kreport.com/methodology