510(k) Report

510(k) · Cleared

Cleared

Softlase G2-Surgical Diode Laser System

K021227510(k) TraditionalCleared Jun 26, 200269-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

Zap Lasers, LLC · GEX Powered Laser Surgical Instrument

Cleared on Jun 26, 2002 as substantially equivalent to K003440 (Zap Lasers, Inc., 2001) and 1 other predicate after a 69-day review. Its family tree reaches back 1 generation to 2001. 56 later devices descend from it.

Decided
Jun 26, 2002
Review
69 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K003385 (2001). 2 ancestors in all. 56 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2008: 1 descendant cleared2009: 2 descendants cleared2006: 1 descendant cleared2010: 5 descendants cleared2011: 2 descendants cleared2021: 2 descendants cleared2015: 2 descendants cleared2013: 3 descendants cleared2012: 1 descendant cleared2020: 3 descendants cleared2022: 4 descendants cleared2014: 1 descendant cleared2016: 3 descendants cleared2019: 2 descendants cleared2017: 1 descendant cleared2018: 3 descendants cleared2025: 9 descendants cleared2023: 2 descendants cleared2024: 4 descendants cleared2026: 5 descendants clearedK003385 · Twilite, Twilite White · Biolase Technology, Inc. · 2001200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 14 descendants5 generations forward: 12 descendants6 generations forward: 5 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant K003385 · Twilite, Twilite White · Biolase Technology, Inc. · 20010+5
  1. Root · 1 generation backK003385 Twilite, Twilite WhiteBiolase Technology, Inc. · 2001
  2. This deviceK021227 Softlase G2-Surgical Diode Laser SystemZap Lasers, LLC · 2002
  3. Descendant · cites it directly · 50 of its ownK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
  4. Descendant · 2 generations on · 35 of its ownK093852 Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010
  5. Descendant · 3 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
  6. Descendant · 4 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
  7. Descendant · cites it directly · 17 of its ownK062071 Prometey, Model G1-03Spectrum International · 2006

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 22010: 52011: 22012: 12013: 32014: 12015: 22016: 32017: 12018: 32019: 22020: 32021: 22022: 42023: 22024: 42025: 92026: 5
2006high 9 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 56 · See all
  • K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008 · cites it directly50descendants
  • K093852Ezlase 3 Laser SystemBiolase Technology, Inc. · 2010 · 2 generations on35descendants
  • K121286EPIC 10Biolase Technology, Inc. · 2012 · 3 generations on31descendants
  • K170500SIROLaser Advance+Dentsply Sirona · 2017 · 4 generations on21descendants
  • K062071Prometey, Model G1-03Spectrum International · 2006 · cites it directly17descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003385Twilite, Twilite WhiteBiolase Technology, Inc.2001—
0 (this device)K021227Softlase G2-Surgical Diode Laser SystemZap Lasers, LLC2002—
+1K081214Styla Microlaser and StylaorthoZap Lasers, LLC2008—
+2K093852Ezlase 3 Laser SystemBiolase Technology, Inc.2010—
+3K121286EPIC 10Biolase Technology, Inc.2012—
+4K170500SIROLaser Advance+Dentsply Sirona2017—
+1K062071Prometey, Model G1-03Spectrum International2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200920
201050
201120
201210
201330
201410
201520
201630
201710
201830
201920
202030
202120
202240
202320
202440
202590
202650
FIG. 1 — Lineage of K021227, 2001–2026Source: 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? (3)

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
*K003440Softlase - Surgical Diode Laser System
Summary page 2
…, Inc. believes that the following surgical laser systems are substantially equivalent to the SoftLase - Surgical Laser Diode System: 1. SOFTLASE (K003440, ZAP Lasers, hc.); 2. AURORA HL (€2392374,Premier Laser Systems, Inc.) and 3. TWILITE (K003385,Biolase Technology,…
Zap Lasers, Inc.2001—
Kept off the family treeK992374FDA’s K992374 is Aurora HL
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Premier Laser Systems, Inc.1999—
*K003385Twilite, Twilite White
Summary page 2
…Lase - Surgical Laser Diode System: 1. SOFTLASE (K003440, ZAP Lasers, hc.); 2. AURORA HL (€2392374,Premier Laser Systems, Inc.) and 3. TWILITE (K003385,Biolase Technology, Inc.). To assist in the overall evaluation of the referenced surgical laser systems, the followin…
Biolase Technology, Inc.2001—

Also cleared against K003440: 1 other device →

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850
K062071Prometey, Model G1-03Spectrum International200617
K083142Picasso Laser SystemAmd Lasers, LLC200916
K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K081214 (Zap Lasers, LLC, 2008) has gone furthest, with 50 descendants of its own.
  • 1 other device also cites its predicate K003440.

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 SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. Thk SofiLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures. The device will be used in the following areas: general and cosmetic…

Read the full statement (175 words)

The SoftLase G2 - Surgical Diode Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. Thk SofiLase G2 is intended for ablating, incising, excising, vaporization and coagulation intraoral soft tissues using a contact fiber optic delivery system. The system is also intended for use in teeth whitening procedures.

The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic s u r g q , neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the indications for use for which the device will be marketed:

-Excision and Incision Biopsies

-Hemostatic assistance

-Treatment of Apthous Ulcers

-Frenectomy

-Frenotomy

-Gingival incision and Excision

-Gingivectomy

-Gingivoplasty

-Incising and Draining of Abscesses

-0perculectomy

-Oral Papillectomy

-Removal of Fibromas

-Exposure of interrupted teeth

-Soft Tissue Crown Lengthening

-Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)

-Tissue retraction for Impression

-Vestibuloplasty

-Light activation of bleaching materials for teeth whitening

-Laser-assisted bleaching f whitening of teeth

Indications for use as stated in the FDA summary.

Also cleared against K003440

1 other device cites the same predicate.

  • K083142Picasso Laser SystemAmd Lasers, LLC · 2009

More from Zap Lasers, LLC

3 FDA decisions under this applicant name. See the company

  • K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC · 2009
  • K081214Styla Microlaser and StylaorthoZap Lasers, LLC · 2008

Recent decisions in GEX

The GEX category page

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  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K021227 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021227: Softlase G2-Surgical Diode Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021227

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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