510(k) Report

510(k) · Cleared

Cleared

Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)

K990903510(k) TraditionalCleared Aug 27, 1999162-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Descendants, by year cleared 2002: 6 descendants cleared2004: 10 descendants cleared2003: 11 descendants cleared2000: 2 descendants cleared2008: 27 descendants cleared2016: 39 descendants cleared2025: 84 descendants cleared2007: 16 descendants cleared2022: 54 descendants cleared2006: 6 descendants cleared2011: 26 descendants cleared2005: 7 descendants cleared2014: 32 descendants cleared2012: 22 descendants cleared2009: 18 descendants cleared2020: 42 descendants cleared2010: 19 descendants cleared2021: 32 descendants cleared2015: 28 descendants cleared2017: 33 descendants cleared2013: 29 descendants cleared2018: 34 descendants cleared2023: 42 descendants cleared2024: 71 descendants cleared2019: 24 descendants cleared2026: 47 descendants cleared1995200020052010201520202025
  1. This deviceK990903 Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Laserscope · 1999
  2. Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  3. Descendant · 2 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  4. Descendant · 2 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
  5. Descendant · 2 generations on · 656 of its ownK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
  6. 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

2000: 22002: 62003: 112004: 102005: 72006: 62007: 162008: 272009: 182010: 192011: 262012: 222013: 292014: 322015: 282016: 392017: 332018: 342019: 242020: 422021: 322022: 542023: 422024: 712025: 842026: 47
2000high 84 (2025) · low 0 (2001)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990903Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Laserscope1999—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
+2K022923Candela Gentle Yag Laser SystemCandela Corp.2003—
+2K023193Candela Gentle Yag Laser SystemCandela Corp.2002—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200020
200260
2003110
2004100
200570
200660
2007160
2008270
2009180
2010190
2011260
2012220
2013290
2014320
2015280
2016390
2017330
2018340
2019240
2020420
2021320
2022540
2023420
2024710
2025840
2026470
FIG. 1 — Lineage of K990903, 1999–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK770723FDA’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 1
Aug 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…
Chattanooga Pharmacal Co.1977—

What descends from it? (761)

See all 761

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739
K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519
K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258
K023881Profile 1064 Laser SystemSciton, Inc2003227
K032220Adept 1064/532 LaserAdept Medical Concepts2003126
K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104
K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822
K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035
K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042
K032221Adept 1064/755 LaserAdept Medical Concepts20030

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 devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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