# K973470: Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in Combination with the Coherent Argons

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Dec 9, 1997 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P830054 (1984). 9 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P830054: Neodymium: Yag Ophthalmic Laser System 9900, Coherent Medical Division (1984) Summary page 1.
- K893987: Nidek Model YC-1200, Nidek, Inc. (1989) Summary page 1.
- K901481: Model YC-1200/Photocoagulator Ophthalmic Laser, Nidek, Inc. (1990) Summary page 1.
- P840012: Microruptor MR-2 ND:Yag Laser System, Meridian AG (1986) Summary page 1.
- K885164: Lasag Microruptor 2 ND:Yag Ophth. Laser System, Chiron Vision Corp. (1989) Summary page 1.
- K926452: Zeiss Visulas Yag II Laser, Carl Zeiss, Inc. (1993) Summary page 1.
- K897099: Model 2800 ND:Yag Ophthalmic Laser, Alcon Surgical, Inc. (1990) Summary page 1.
- K893709: Coherent Marie Argon Photocoagulator, Coherent Medical Group (1989) Summary page 1.
- K913127: Coherent Novus 3000 Argon Photocoagulator, Coherent Medical Group (1991) Summary page 1.

## Most influential descendants
- K032357: Novus TTX Laser and Delivery Devices with Accessories (2003), 5 descendants of its own
- K052526: Novus 3000 Laser System and Delivery Devices (2005), 4 descendants of its own
- K062336: Optimedica Laser Indirect Ophthalmoscope (2006), 1 descendant of its own
- K061025: Accutech Endolite Probe (2006), 1 descendant of its own
- K051944: Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo), Delivery Device and Accessories (2005), 1 descendant of its own

## Indications for use
The Coherent Popeye Ophthalmic Laser is indicated for use in photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser. These indications include: discission of the posterior capsule of the eye (posterior capsulotomy) discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients The Coherent Popeye Ophthalmic Laser in Combination with the Ultima 2000 or Ultima 2000SE Argon Photocoagulator is indicated for: a. Popeye Nd:YAG 1064 nm wavelength - Indicated for use in photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser. These indications include: o discission of the posterior capsule of the eye (posterior capsulotomy) and; e discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients. b. Ultima 2000/Ultima 2000SE - Indicated for use in the treatment of ocular pathology using blue-green and green argon laser energy. These indications include: e photocoagulation of both anterior and posterior segments including: e iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma; e retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including; - diabetic retinopathy; - choroidal neovascularization; - branch retinal vein occlusion; - subretinal neovascularization in disciform macular degeneration. The Coherent Popeye Ophthalmic Laser in Combination with the Ultima 2000 or Ultima 2000SE Argon Photocoagulator (Indications continued) Laser Indirect Ophthalmoscope The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: o diabetic retinopathy (pan-retinal photocoagulation); e retinopexy; e segmental peripheral photocoagulation; e segmental photocoagulation; ¢ cloudy vitreous cavities; and, o pediatric retinal repairs (under general anesthesia) Acculite Endoprobe The Acculite Endoprobe is indicated for use in the following ophthalmic applications: ¢ photocoagulation of the anterior and posterior segment, including: - anterior segment treatment in the surgical management of glaucoma; - endophotocoagulation in vitreoretinal surgery - including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

Source page: https://510kreport.com/device/K973470
Methodology: https://510kreport.com/methodology