510(k) · Cleared
ClearedNeoLas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheaumann Laser, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 22, 2015 as substantially equivalent to K120377 (J. Morita USA, Inc., 2012) and 1 other predicate after a 281-day review. Its family tree reaches back 12 generations to 1992. 1 later device descends from it.
- Decided
- Dec 22, 2015
- Review
- 281 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K910422 (1992). 129 ancestors in all, the oldest K820106 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 2 generations backK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- 1 generation backK120377 Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc. · 2012
- This deviceK150664 NeoLasSheaumann Laser, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK254197 Picasso Pro Diode Laser (002-00460)CAO Group, Inc. · 2026
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 3 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 2 generations backK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- 1 generation backK120377 Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc. · 2012
- This deviceK150664 NeoLasSheaumann Laser, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −3 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −2 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| −1 | K120377 | Adverl Evo ER: Yag Laser for Dentistry Mey-1-a | J. Morita USA, Inc. | 2012 | — |
| 0 (this device) | K150664 | NeoLas | Sheaumann Laser, Inc. | 2015 | — |
| +1 | K254197 | Picasso Pro Diode Laser (002-00460) | CAO Group, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K120377 | Adverl Evo ER: Yag Laser for Dentistry Mey-1-aSummary page 6…Predicate Devices (Claiming Substantial Equivalence): MEY-1-A K120377 Picasso Lite K102359… | 2012 |
| * | K102359 | Picasso/ Picasso Lite/ Picasso PerioSummary page 6…K120377 Picasso Lite K102359 Summary Description of Device: NeoLas is a portable, microprocessor controlled dual laser system with both ER:YAG and Soft Tiss… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254197 | Picasso Pro Diode Laser (002-00460) | 2026 | 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?
- The line of descent spans 23 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 129 ancestors have a recall of any class.
- Of its descendants, K254197 (CAO Group, Inc., 2026) has gone furthest, with 0 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. 2015, this device’s year, is highlighted.
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 NeoLas Er:YAG laser. and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures: In dentistry for: Endodontic Surgery (Root Amputation) Indications: * Root end preparation for retrofill amalgam or composite * Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex. NOTE: Any tissue growth (i.e. cyst, neoplasm…
Read the full statement (406 words)
The NeoLas Er:YAG laser. and its accessories, are intended for use in dentistry, dermatology and other surgical areas in the following procedures:
In dentistry for:
Endodontic Surgery (Root Amputation) Indications:
* Root end preparation for retrofill amalgam or composite
* Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex.
NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
Laser Periodontal Procedures:
» Full thickness flap
» Partial thickness flap
» Split thickness flap
» Laser soft tissue curettage
* Laser removal of diseased, infected. inflamed and necrosed soft tissue within the periodontal pocket
* Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
* Removal of granulation tissue from bony defects
* Sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures:
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including:
* Excisional and incisional biopsies
* Exposure of unerupted teeth
* Fibroma removal
* Flap preparation—incision of soft tissue to prepare a flap and expose the bone.
* Flap preparation—incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions)
* Frenectomy and frenotomy
* Gingival troughing for crown impressions
* Gingivectomy
* Gingivoplasty
* Gingival incision and excision
» Hemostasis and coagulation
* Implant recovery
» Incision and drainage of abscesses
* Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery
* Leukoplakia
* Operculectomy
* Oral papillectomies
* Pulpotomy
» Pulp extirpation
* Pulpotomy as an adjunct to root canal therapy
» Reduction of gingival hypertrophy
* Removal of pathological tissues (i.e. cyst, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex
* Root canal debridement and cleaning
» Soft tissue crown lengthening
* Treatment of canker sores, herpetic and aphthous ulcer of the oral mucosa
* Vestibuloplasty
NOTE: Any tissue growth (i.e. cyst. neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation
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/K150664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150664: NeoLas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150664
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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