510(k) · Cleared
ClearedLaserscope Vela Erbium:Yag Laser System and Accessories
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 Jul 23, 1997 after a 70-day review. The FDA summary names its predicate without a number. 573 later devices descend from it.
- Decided
- Jul 23, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
573 later devices descend from it, 7 citing it directly.
- This deviceK971843 Laserscope Vela Erbium:Yag Laser System and AccessoriesLaserscope · 1997
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Showing 5 of 573 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 573 · See all- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971843 | Laserscope Vela Erbium:Yag Laser System and Accessories | Laserscope | 1997 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +3 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 8 | 0 |
| 2010 | 17 | 0 |
| 2011 | 18 | 0 |
| 2012 | 18 | 0 |
| 2013 | 16 | 0 |
| 2014 | 24 | 0 |
| 2015 | 26 | 0 |
| 2016 | 34 | 0 |
| 2017 | 30 | 0 |
| 2018 | 31 | 0 |
| 2019 | 14 | 0 |
| 2020 | 35 | 0 |
| 2021 | 28 | 0 |
| 2022 | 45 | 0 |
| 2023 | 34 | 0 |
| 2024 | 63 | 0 |
| 2025 | 63 | 0 |
| 2026 | 38 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System Named without a submission number |
What descends from it? (573)
See all 5737 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 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 Laserscope VELA Erbium:YAG Laser System and Accessories are intended for the surgical incision/excision, vaporization and coagulation of soft tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Dermatology/Plastic Surgery: Indications include, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids…
Read the full statement (225 words)
The Laserscope VELA Erbium:YAG Laser System and Accessories are intended for the surgical incision/excision, vaporization and coagulation of soft tissue. All soft tissue is included, such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology/Plastic Surgery: Indications include, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers and skin resurfacing.
General Surgery: The Erbium:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
ENT: Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis; excision of carcinogenic tissue, oral leukoplakia.
Oral/Maxillofacial: Indications include benign oral tumors, oral and glossal lesions and gingivectomy.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
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/K971843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971843: Laserscope Vela Erbium:Yag Laser System 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/K971843
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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