510(k) · Cleared
ClearedAdverl Evo ER: Yag Laser for Dentistry Mey-1-a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 25, 2012 as substantially equivalent to K041710 (Hoya Conbio, 2004) and 1 other predicate after a 170-day review. Its family tree reaches back 11 generations to 1992. 2 later devices descend from it.
- Decided
- Jul 25, 2012
- Review
- 170 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K910422 (1992). 127 ancestors in all, the oldest K820106 (1982). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 1 generation backK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- This deviceK120377 Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK150664 NeoLasSheaumann Laser, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK254197 Picasso Pro Diode Laser (002-00460)CAO Group, Inc. · 2026
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 3 generations backK050293 Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP…Fotona D.D. · 2005
- 2 generations backK070355 Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D. · 2008
- 1 generation backK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- This deviceK120377 Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −4 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −3 | K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag… | Fotona D.D. | 2005 | — |
| −2 | K070355 | Fotona Fidelis Iii ER:Yag/ND:Yag Laser System Family | Fotona D.D. | 2008 | — |
| −1 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| 0 (this device) | K120377 | Adverl Evo ER: Yag Laser for Dentistry Mey-1-a | J. Morita USA, Inc. | 2012 | — |
| +1 | K150664 | NeoLas | Sheaumann Laser, Inc. | 2015 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K041710 | Versawave Dental ER:Yag Laser SystemSummary page 1…dentistry. Predicate devices and Indications of use: The MEY1-A is substantially equivalent to both predicate devices of 'VERSAWAVE DENTAL ER:YAG LASER SYSTEM (K#041710) "made by HOYA CONBIO and .WATERLASE MD TURBO PLUS MODEL 7200XXX( K#101658)" made by BIOLASE TECHNOLOGY, INC. The indicatio… | 2004 |
| * | K101658 | Waterlase MD Turbo Plus Model 7200XXXSummary page 1…bstantially equivalent to both predicate devices of 'VERSAWAVE DENTAL ER:YAG LASER SYSTEM (K#041710) "made by HOYA CONBIO and .WATERLASE MD TURBO PLUS MODEL 7200XXX( K#101658)" made by BIOLASE TECHNOLOGY, INC. The indications of use of the MEY-I-A covers all identical indications of "VERSAWAVE DENTA… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150664 | NeoLas | 2015 | 1 |
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 20 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 127 ancestors have a recall of any class.
- Of its descendants, K150664 (Sheaumann Laser, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K041710.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Hard Tissue General Indications* - Class 1,11,Ill; IV and V cavity preparation - Caries removal * Hard tissue surface roughening or etching - Enameloplasty, excavation of pits and fissures for placement of sealants *For use on adult and pediatric patients Root Canal Hard Tissue Indications * Tooth preparation to obtain access to root canal * Root canal preparation including enlargement * Root canal debridement and cleaning Bone Surgical Indications -…
Read the full statement (527 words)
Hard Tissue
General Indications*
- Class 1,11,Ill; IV and V cavity preparation
- Caries removal
* Hard tissue surface roughening or etching
- Enameloplasty, excavation of pits and fissures for placement of sealants
*For use on adult and pediatric patients
Root Canal Hard Tissue Indications
* Tooth preparation to obtain access to root canal
* Root canal preparation including enlargement
* Root canal debridement and cleaning
Bone Surgical Indications
- Cutting, shaving, contouring and resection of oral osseous tissues (bone)
* Osteotomy
Endlodontic Surgery (Root Amputation) Indications
* Flap preparation - incision of soft tissue to prepare a flap and expose the bone.
* Cutting bone to prepare a window access to the apex (apices) of the root(s).
* Apicoectomy - amputation of the root end.
* 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)
- Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiological osseous contours)
*Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.)
* Osseous crown lengthening
* Removal of subgingival calculus
Soft Tissue Indications including Pulpal Tissues*
Incision, excision, vaporization, ablation and coagulation of 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
* Incision and drainage of periapical 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. 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.
* Root canal debridement and cleaning
* Soft tissue crown lengthening
* Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
* Vestibuloplasty
*For use on adult and pediatric patients
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120377 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120377: Adverl Evo ER: Yag Laser for Dentistry Mey-1-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120377
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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