510(k) · Cleared
ClearedDoctor Smile a-810 and B-980 Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lambda Scientific Spa · GEX Powered Laser Surgical Instrument
Cleared on Sep 8, 2009 as substantially equivalent to K073322 (A.R.C Laser GmbH, 2008) and 5 other predicates after a 103-day review. Its family tree reaches back 17 generations to 1995. 8 later devices descend from it.
- Decided
- Sep 8, 2009
- Review
- 103 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 17 generations to K943450 (1995). 197 ancestors in all, the oldest K800617 (1980). 8 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- This deviceK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- Descendant · cites it directly · 7 of its ownK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- Descendant · 2 generations on · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- Descendant · 3 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK251077 JOULE 1064nm System and AccessoriesSciton, Inc · 2025
- Descendant · 4 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 1 generation backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- This deviceK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010 · cites it directly7descendants
- K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013 · 2 generations on6descendants
- K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · 3 generations on3descendants
- K251077JOULE 1064nm System and AccessoriesSciton, Inc · 2025 · 3 generations on0descendants
- K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −4 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −3 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −1 | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C Laser GmbH | 2008 | — |
| 0 (this device) | K091562 | Doctor Smile a-810 and B-980 Lasers | Lambda Scientific Spa | 2009 | — |
| +1 | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| +2 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| +3 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +3 | K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | 2025 | — |
| +4 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems… | Wuhan Dimed Laser Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 14 | 0 |
| 1996 | 15 | 0 |
| 1997 | 21 | 0 |
| 1998 | 11 | 0 |
| 1999 | 10 | 0 |
| 2000 | 15 | 0 |
| 2001 | 15 | 0 |
| 2002 | 17 | 0 |
| 2003 | 14 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810Summary page 1…___--_ Predicate Devices Doctor Smile A-81 0, B-980.Lasers - Arc Laser GmbH Fox Q-8 10, Q-980 K073322 - Biolase EzlaseV K082938 - Sirona Sirolaser K0… | 2008 |
| * | K082938 | EzlaseSummary page 1…Smile A-81 0, B-980.Lasers - Arc Laser GmbH Fox Q-8 10, Q-980 K073322 - Biolase EzlaseV K082938 - Sirona Sirolaser K053161 * - Kayo Gentleray 980… | 2008 |
| * | K053161 | SirolaserSummary page 1…- Arc Laser GmbH Fox Q-8 10, Q-980 K073322 - Biolase EzlaseV K082938 - Sirona Sirolaser K053161 * - Kayo Gentleray 980 K072262 - Ceralas 980 K072… | 2006 |
| * | K072262 | Gentleray 980 Diode Laser SystemSummary page 1…- Biolase EzlaseV K082938 - Sirona Sirolaser K053161 * - Kayo Gentleray 980 K072262 - Ceralas 980 K072779 - Claros Nano Dental Lase… | 2007 |
| * | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary page 1…- Sirona Sirolaser K053161 * - Kayo Gentleray 980 K072262 - Ceralas 980 K072779 - Claros Nano Dental Laser System K08 1652- Product description D… | 2008 |
| * | K081652 | Claros Nano Dental Laser SystemSummary page 1…- Kayo Gentleray 980 K072262 - Ceralas 980 K072779 - Claros Nano Dental Laser System K08 1652- Product description Doctor Smile A-8 10, B-980 Lasers are the same standard diode… | 2008 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102036 | Doctor Surgery Diode Lasers Family | 2010 | 7 |
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 14 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 8 of the 197 ancestors have a recall of any class.
- Of its descendants, K102036 (Lambda S.P.A., 2010) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K073322.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Doctor Smile A-810 Laser is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening Intra- and extra oral surgery including incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue, curettage, whitening. Following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival…
Read the full statement (278 words)
Doctor Smile A-810 Laser is intended for use in the following procedure:
Soft Tissue, Laser Periodontal procedures and tooth whitening Intra- and extra oral surgery including incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue, curettage, whitening.
Following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision Haemostasis and coagulation, Implant recovery, Incision and drainage of abscess Leukoplakia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty. Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket. Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.). Light activation of whitening/bleaching material.
Doctor Smile B-980 Laser is intended for use in the following procedure:
Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissue in medical specialties including dentistry, gastroenterology, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics.
Dental applications:
Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Haemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091562: Doctor Smile a-810 and B-980 Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091562
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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