510(k) Report

510(k) · Cleared

Cleared

Spectra Vrmii 1-Switched ND:Yag Laser System

K073436510(k) TraditionalCleared Dec 28, 200722-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

Lutronic Corporation · GEX Powered Laser Surgical Instrument

Cleared on Dec 28, 2007 after a 22-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided
Dec 28, 2007
Review
22 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared20052010201520202025
  1. This deviceK073436 Spectra Vrmii 1-Switched ND:Yag Laser SystemLutronic Corporation · 2007
  2. Descendant · cites it directly · 0 of its ownK102050 Q-Switched ND:Yag Laser System, Model Globalcure-SC6Advanced Technology Laser Co., Ltd. · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K102050Q-Switched ND:Yag Laser System, Model Globalcure-SC6Advanced Technology Laser Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073436Spectra Vrmii 1-Switched ND:Yag Laser SystemLutronic Corporation2007—
+1K102050Q-Switched ND:Yag Laser System, Model Globalcure-SC6Advanced Technology Laser Co., Ltd.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K073436, 2007–2010Source: 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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Lutronic Spectra QT Q-switched Nd:YAG Laser System
Named without a submission number
—
*—Tissue Medical Spectra-VRM Q-switched Nd:YAG Laser System
Named without a submission number
—
*—Altus Medical CoolGlide Aesthetic Lasers
Named without a submission number
—
*—Fotona QX Nd:YAG/KTP Laser System
Named without a submission number
—
*—NaturaLase LP with 532 Hand Piece
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102050Q-Switched ND:Yag Laser System, Model Globalcure-SC6Advanced Technology Laser Co., Ltd.20100

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, K102050 (Advanced Technology Laser Co., Ltd., 2010) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.

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 Spectra VRMII Laser System in indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. * 532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Caf&-Au-Lait Treatment of Seborrheic Keratoses…

Read the full statement (116 words)

The Spectra VRMII Laser System in indicated for the incision, excision, ablation,

vaporization of soft tissues for general dermatology, dermatologic and general surgical

procedures for coagulation and hemostasis.

* 532nm Wavelength: Removal of light ink (Red, Tan, Purple, and Orange)

Tattoos

Removal of Epidermal Pigmented Lesions

Removal of Minor Vascular Lesions

Treatment of Lentigines

Treatment of Caf&-Au-Lait

Treatment of Seborrheic Keratoses

Treatment of Post Inflammatory Hyper-Pigmentation

Treatment of Becker's Nevi, Freckles and Nevi Spilus

1064nm Wavelength: Removal of dark ink (Black, Blue and Brown)

Tattoos

Removal of Nevus of Ota

Removal of lightening of unwanted hair with or without

adjuvant preparation.

Treatment of Common Nevi

Skin resurfacing procedures for the treatment of acne scars

and wrinkles

Indications for use as stated in the FDA summary.

More from Lutronic Corporation

29 FDA decisions under this applicant name. See the company

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https://510kreport.com/device/K073436 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073436: Spectra Vrmii 1-Switched ND:Yag Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073436

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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