510(k) · Cleared
ClearedLyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laserscope · GEX Powered Laser Surgical Instrument
Cleared on Aug 27, 1999 after a 162-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 761 later devices descend from it.
- Decided
- Aug 27, 1999
- Review
- 162 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
761 later devices descend from it, 13 citing it directly.
- This deviceK990903 Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Laserscope · 1999
- Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- Descendant · 2 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · 2 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
- Descendant · 2 generations on · 656 of its ownK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- Descendant · 3 generations on · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
Showing 5 of 761 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 761 · See all- K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · cites it directly739descendants
- K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 2 generations on665descendants
- K022923Candela Gentle Yag Laser SystemCandela Corp. · 2003 · 2 generations on656descendants
- K023193Candela Gentle Yag Laser SystemCandela Corp. · 2002 · 2 generations on656descendants
- K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · 3 generations on654descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990903 | Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration) | Laserscope | 1999 | — |
| +1 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| +2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +2 | K022923 | Candela Gentle Yag Laser System | Candela Corp. | 2003 | — |
| +2 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| +3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 27 | 0 |
| 2009 | 18 | 0 |
| 2010 | 19 | 0 |
| 2011 | 26 | 0 |
| 2012 | 22 | 0 |
| 2013 | 29 | 0 |
| 2014 | 32 | 0 |
| 2015 | 28 | 0 |
| 2016 | 39 | 0 |
| 2017 | 33 | 0 |
| 2018 | 34 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 32 | 0 |
| 2022 | 54 | 0 |
| 2023 | 42 | 0 |
| 2024 | 71 | 0 |
| 2025 | 84 | 0 |
| 2026 | 47 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K770723 | FDA’s K770723 is Table, Treatment, Therapy, Physical Our OCR of the scanned summary read K770723, FDA’s number for Table, Treatment, Therapy, Physical (Chattanooga Pharmacal Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Laserscope ORION Surgical Laser System”. Kept off the family tree. Summary page 1Aug 20 89 12:43p Laserscope (408) 843-8235 AUG 27 1oy K 770723 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE Lyra SURGICAL LASER SYSTEM REGULATORY AUTHORITY Safe Medical Device Act of… | 1977 |
What descends from it? (761)
See all 76113 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 | 739 |
| K033251 | The Friendlylight ND: Yag Lasers | 2004 | 519 |
| K994260 | Candela Gentlelase GL Dermatological Laser | 2000 | 258 |
| K023881 | Profile 1064 Laser System | 2003 | 227 |
| K032220 | Adept 1064/532 Laser | 2003 | 126 |
| K032218 | Adept 1064/532/755 Laser | 2003 | 104 |
| K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | 2008 | 22 |
| K031828 | Naturalase LP ND:Yag Laser | 2003 | 5 |
| K032397 | Dual Yellow Laser, Model Dual Yellow D10B | 2004 | 2 |
| K032221 | Adept 1064/755 Laser | 2003 | 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?
- Of its descendants, K014040 (Altus Medical, Inc., 2002) has gone furthest, with 739 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The LYRA Series Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. KTP/532 Applications Dermatology: Photocoagulation of cutaneous lesions including but not limited to…
Read the full statement (662 words)
The LYRA Series Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
KTP/532 Applications
Dermatology: Photocoagulation of cutaneous lesions including but not limited to the following general categories of lesions: Vascular lesions (Angiomas, Hemangiomas, Telangiectasia); Benign pigmented lesions (Nevi, Lentigines, Chloasma, Café-au-lait, Tattoos (including but not limited to blue and black dark tattoo ink); Verrucae; Skin Tags; Keratoses; Plaques; Cutaneous Lesion Treatment (Hemostasis, Color Lightening, Blanching, Flattening, Reduction of lesion size).
General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft tissue as well as in Endoscopic (e.g. laparoscopic) or open surgeries.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).
Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: Endometriosis; Cervical, vulvar, and vaginal intraepithelial neoplasia; Condyloma Acuminata; Uterine Septum; Intrauterine adhesions; Submucosal fibroids.
Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.
Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.
Opthamology: Post-vitrectomy endophotocoagulation of the retina.
Plastic Surgery: Vaparizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscapic and open procedures.
Spinal Surgery: Percutaneous lumbar diskectomy.
Thoracic Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.
Urology: Cutting, coagulating, or vaporizing urologic soft tissues.
ND:YAG/1064 Applications
Dermatology: Photocoagulation of pigmented lesions to reduce lesion size. For patients with lesions that would potentially benefit from aggressive treatment. For patients with lesions that have not responded to other laser treatments.
Endoscopic/Laparoscopic General Surgery: Cutting, ablation, and/or hemostasis of soft tissue in endoscopic or laparoscopic general surgery applications, including but not limited to: Cholecystectomy, Appendectomy, Vagotomy, Pyloromyotomy.
Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions including Squamous cell carcinoma and Adenocarcinoma; Gastrointestinal hemostasis including: Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal uicers, non-bleeding ulcers, Gastric erosions; Gastrointestinal tissue ablation including: Benign and malignant neoplasm; Angiodysplasia; Polyps; Uicer; Colitis; Hemorrhoids.
General Surgery: Soft tissue general surgery applications: Skin incision; Tissue dissection; Excision of extemnal tumors and lesions; compiete or partial resection of internal organs, tumors, lesions; Tissue ablation; Vessel Coagulation.
Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus; Ablation of endometrial implants and/or peritoneal adhesions; Soft tissue excisional procedures, such as excisional conization of the cervix; intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including Submucous fibroids, Benign endometrial polyps, Uterine septum.
Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.
Hemostasis during Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscapic) and open procedures.
Neurosurgery: Hemostasis for: Pituitary Tumor; Meningioma; Hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Oculoplastics: incision, Excision, Vaporization and/or coagulation of tissues in Oculoplastic procedures such as: Operations on the lacrimal system; Operation on the eyelids; Removal of biopsy or orbital tumors; Enucleation on eyeball; Exteneration of orbital contents.
Orthopedics: Cutting, ablation, and/or hemostasis of intra-adicular tissue in Orthopedic surgical and arthroscopic applications.
Plastic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue.
Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including: Squamous Cell Carcinoma; Adenocarcinoma; Carcinoid; Benign Tumors; Granuiomas; Benign Strictures.
Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue. Thoracic applications including, but not limited to: Isolation of vessels for endarterectomy and/or by-pass grafts; Wedge Resections ; Thoractomy; Formation of Pacemaker pockets. Vaporization, coagulation, incision/excision, debulking, and ablation of fung tissue (Thoracoscopy).
Urology: All applications including: Superficial urinary bladder tumors; Invasive bladder carcinoma; Urethral Strictures; Lesions of the extemnal genitalia (including condyloma acuminata).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990903 · printed Nov 3, 2026
Cite this page
510(k) Report. “K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K990903
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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