510(k) · Cleared
ClearedSoftlase Pro, Ortholase and Hygienelase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zap Lasers, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jul 31, 2009 as substantially equivalent to K021227 (Zap Lasers, LLC, 2002) and 2 other predicates after a 44-day review. Its family tree reaches back 7 generations to 1992. 2 later devices descend from it.
- Decided
- Jul 31, 2009
- Review
- 44 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K922901 (1992). 25 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
- 6 generations backK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
- 5 generations backK983058 Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc. · 1998
- 4 generations backK991891 Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc. · 1999
- 3 generations backK053161 SirolaserSirona Dental Systems GmbH · 2006
- 2 generations backK062258 Genesis Diode LaserIvoclar Vivadent, Inc. · 2007
- 1 generation backK081214 Styla Microlaser and StylaorthoZap Lasers, LLC · 2008
- This deviceK091796 Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC · 2009
- Descendant · cites it directly · 1 of its ownK102639 SL3Discus Dental, LLC · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK141838 Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC · 2014
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 |
|---|---|---|---|---|---|
| −7 | K922901 | Incisor I Pulsed ND:Yag Laser System | Buckman Co., Inc. | 1992 | — |
| −6 | K972325 | Pulsemaster 1000 ST Dental Laser System | American Dental Technologies, Inc. | 1997 | — |
| −5 | K983058 | Ceralas D Laser System, Model # Ceralas D15 | Ceram Optec, Inc. | 1998 | — |
| −4 | K991891 | Ceralas Diode Laser System, Model Ceralas D15 | Ceram Optec, Inc. | 1999 | — |
| −3 | K053161 | Sirolaser | Sirona Dental Systems GmbH | 2006 | — |
| −2 | K062258 | Genesis Diode Laser | Ivoclar Vivadent, Inc. | 2007 | — |
| −1 | K081214 | Styla Microlaser and Stylaortho | Zap Lasers, LLC | 2008 | — |
| 0 (this device) | K091796 | Softlase Pro, Ortholase and Hygienelase | Zap Lasers, LLC | 2009 | — |
| +1 | K102639 | SL3 | Discus Dental, LLC | 2010 | 1 |
| +2 | K141838 | Sol Portable Diode Laser Unit (with Wireless Foot Control) | Regulatory Technology Services, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021227 | Softlase G2-Surgical Diode Laser SystemSummary page 2…g surgical laser systems are substantially equivalent to the SoftLase Pro/OrthoLase/I-ygieneLaseFamily ofproducts surgical diode system. 1. SoftLase G2 (K021227, Zap Lasers, LLC) 2. ODYSSEY NAVIGATOR (K062258, Ivoclar Vivadent, Inc.) 3. STYLA MICROLASER/STYLAORTHO Diode Las… | 2002 |
| * | K062258 | Genesis Diode LaserSummary page 2…the SoftLase Pro/OrthoLase/I-ygieneLaseFamily ofproducts surgical diode system. 1. SoftLase G2 (K021227, Zap Lasers, LLC) 2. ODYSSEY NAVIGATOR (K062258, Ivoclar Vivadent, Inc.) 3. STYLA MICROLASER/STYLAORTHO Diode Laser System (K081214, Zap Lasers LLC.) 10. Summary of Equ… | 2007 |
| * | K081214 | Styla Microlaser and StylaorthoSummary page 2…1. SoftLase G2 (K021227, Zap Lasers, LLC) 2. ODYSSEY NAVIGATOR (K062258, Ivoclar Vivadent, Inc.) 3. STYLA MICROLASER/STYLAORTHO Diode Laser System (K081214, Zap Lasers LLC.) 10. Summary of Equivalence: There are no unique applications, indications, material or specifications pres… | 2008 |
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 |
|---|---|---|---|
| K102639 | SL3 | 2010 | 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 17 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 25 ancestors has a recall of any class.
- Of its descendants, K102639 (Discus Dental, LLC, 2010) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K021227.
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?
The SoftLase ProTm/OrthoLaseTm/HygieneLaseTM is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SoftLase ProTM/OrthoLaseTM/HygieneLaseTM is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system. The device will be used in the following areas: general and cosmetic dentistry. otolaryngology, arthroscopy…
Read the full statement (149 words)
The SoftLase ProTm/OrthoLaseTm/HygieneLaseTM is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SoftLase ProTM/OrthoLaseTM/HygieneLaseTM is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.
The device will be used in the following areas: general and cosmetic dentistry. otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralphamgeal 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
-Operculectomy
-Oral Papillectomy
-Removal of Fibromas
-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/whitening of teeth
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091796 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091796: Softlase Pro, Ortholase and Hygienelase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091796
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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