# K972514: Laserex LP1532 Photocoagulator

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Oct 3, 1997 after 88 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.
30 later devices descend from it; 1 cites it directly.
0 of 31 devices 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) Alcon Ophthalas 532: named in the summary without a submission number
- (no number) Alcon Eyelite: named in the summary without a submission number
- (no number) Iris Occulite: named in the summary without a submission number
- (no number) Nidek Prima: named in the summary without a submission number

## Most influential descendants
- K043486: Pascal Photocoagulator, Product-Pascal-01 (2005), 29 descendants of its own
- K091666: Pascal Photocoagulator, Pascal-US (2009), 23 descendants of its own
- K092621: Pascal Streamline Photocoagulator (2009), 22 descendants of its own
- K081744: Pascal Synthesis Delivery System (2008), 17 descendants of its own
- K100019: Pascal Streamline Photocoagulator (2010), 16 descendants of its own

## Indications for use
The indication for use for this product are; » Retinal Photocoagulation « Photocoagulation for Macular Degeneration « Pan Retinal Photocoagulation ¢ Laser Trabeculoplasty « Endophotocoagulation. A General Description of these Treatments are; The indications for use for this product are: Retinal treatments, including; . Retinal Photocoagulation . Pan Retinal Photocoagulation . Endophotocoagulation These treatments involve the destruction of neovascular complexes, to obliterate areas of microinfarction or capillary closure. Retinal Photocoagulation will be carried out using principally the Slittamp Delivery System accessory. Pan Retinal Photocoagulation will be carried out using either of the Laser Indirect Ophthalmoscope or the Slitlamp Delivery System accessory. Endophotocoagulation will be carried out using any one of the three variants of the endoprobe accessories, namely Straight, Curved or Aspirating Endooccular Probes. Photocoagulation for Macular Degeneration involves the destruction of leaking vessels in the macular and paramacular region, and ultimately to produce a chorioretinal adhesion that will resist ongoing vitreoretinal traction. This treatment will be carried out using the slittamp microscope mounted Slitlamp Delivery System accessory. Laser Trabeculoplasty, the photocoagulation of the trabecular meshwork to create apertures and increase the flow of the aqueous humor in order to treat open-angle-glaucoma. This treatment will be tarried out using the slittamp microscope mounted Slittamp Delivery System accessory.

Source page: https://510kreport.com/device/K972514
Methodology: https://510kreport.com/methodology