510(k) · Cleared
ClearedDental 5 Multi Diode laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Med USA, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 15, 2017 as substantially equivalent to K063384 (Hoya Conbio, Inc., 2007) after a 143-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- May 15, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922901 (1992). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 5 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 4 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 3 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 2 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 1 generation backK063384 Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc. · 2007
- This deviceK163638 Dental 5 Multi Diode laserBio-Med USA, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −5 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −4 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −3 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −2 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −1 | K063384 | Diodent Micro Dental Laser System, Models 810 and 980 | Hoya Conbio, Inc. | 2007 | — |
| 0 (this device) | K163638 | Dental 5 Multi Diode laser | Bio-Med USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K063384 | Diodent Micro Dental Laser System, Models 810 and 980Summary page 4…c Surgery. Product Code GEX Type of submission Traditional 4. Legally marketed Predicate Device K063384 DioDen Micro 810/980 Diode Laser Hoya ConBio, Inc Dental 5 Multi wave Diode Laser system pro… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 6 companies; a new generation was cleared every 4.8 years on median.
- None of the 16 ancestors has a recall.
- 4 other devices also cite its predicate K063384.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
This device indicated for use the Incision, Alblation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Un-erupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingival Incision and Excision, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral Papillectomies, Pulpotomy, Pulpotomy as an…
Read the full statement (95 words)
This device indicated for use the Incision, Alblation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Un-erupted teeth, Fibroma Removal,
Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingival Incision and Excision, 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, Sulcular debridement, Treatment of aphthous ulcers Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal,
Light activation for bleaching material, for laser assisted bleaching/ whitening for teeth.
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/K163638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163638: Dental 5 Multi Diode laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163638
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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