510(k) · Cleared
ClearedFamily of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo), Delivery Device and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · HQF Laser, Ophthalmic
Cleared on Sep 30, 2005 as substantially equivalent to K021550 (Ellex Medical Pty, Ltd., 2002) and 3 other predicates after a 74-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Sep 30, 2005
- Review
- 74 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K894841 (1989). 23 ancestors in all, the oldest K812219 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 2 generations backK960971 Oculight GLIriderm Div. · 1996
- 1 generation backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- This deviceK051944 Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta…Lumenis, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK060338 Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT…Lumenis, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060338Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta Duet…Lumenis, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −2 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −1 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| 0 (this device) | K051944 | Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta… | Lumenis, Inc. | 2005 | — |
| +1 | K060338 | Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta… | Lumenis, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021550 | Lumenis Selecta DuetSummary page 1…Plastic Surgery Panel GEX, Laser powered surgical instrument III. Predicate Devices *Lumenis Selecta Duet (K(021550) *Coherent Popeye Ophthalmic Laser and Coherent Popeye Ophthalmic Laser in Combination with the Coheren… | 2002 |
| * | K973470 | Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in…Summary page 1…opeye Ophthalmic Laser in Combination with the Coherent Ultimna 2000 Laser Photocoagulator Coherent Popeye Nd:YAG Ophthalmic Laser Systems (K(973470) *Selecta. 7000 Frequency Doubled Q-Switched Nd:YAG Ophthalmic Laser (K(004006) *LaserL-ink Z-lI000 (K022… | 1997 |
| * | K004006 | Selecta 7000 Frequency Doubled, Q-Switched ND:Yag Ophthalmic LaserSummary page 1…otocoagulator Coherent Popeye Nd:YAG Ophthalmic Laser Systems (K(973470) *Selecta. 7000 Frequency Doubled Q-Switched Nd:YAG Ophthalmic Laser (K(004006) *LaserL-ink Z-lI000 (K02218 1) IV. Product Description The Lumenis Selecta is a fully integrated f… | 2001 |
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 1…Nd:YAG Ophthalmic Laser Systems (K(973470) *Selecta. 7000 Frequency Doubled Q-Switched Nd:YAG Ophthalmic Laser (K(004006) *LaserL-ink Z-lI000 (K02218 1) IV. Product Description The Lumenis Selecta is a fully integrated flash lamp pumped, solid state, Nd:YAG… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060338 | Family of Selecta Laser Systems Including Selecta 1064, Selecta SLT, Selecta Duet… | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K060338 (Lumenis, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K021550.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Selecta 1064: photodisruption of ocular tissue using Light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy Selecta SLT: selective laser trabeculoplasty Selecta Duo: photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including…
Read the full statement (199 words)
Selecta 1064: photodisruption of ocular tissue using Light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy
Selecta SLT: selective laser trabeculoplasty
Selecta Duo: photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphaldc and pseudophakic patients, and iridotomy/iridectomy; and selective laser trabeculoplasty
The Selecta 1064, Selecta SLT and Selecta Duo Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically,
An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment.
LaserLink S: laser delivery system for use by an ophthalmologist in the treatment of ocular tissue; laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051944: Family of Selecta Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duo), Delivery Device and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051944
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026