510(k) · Cleared
ClearedPerioLase Nd:YAG Pulsed Dental Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millennium Dental Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 15, 2016 as substantially equivalent to K030290 (Millennium Dental Technologies, Inc., 2004) after a 260-day review. Its family tree reaches back 1 generation to 2004. 22 later devices descend from it.
- Decided
- Mar 15, 2016
- Review
- 260 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030290 (2004). 22 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030290 Periolase ND:Yag Dental Laser SystemMillennium Dental Technologies, Inc. · 2004
- This deviceK151763 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2016
- Descendant · cites it directly · 20 of its ownK172819 LightWalker Laser System FamilyFotona D.O.O. · 2017
- Descendant · 2 generations on · 19 of its ownK191554 LightWalker Laser System FamilyFotona D.O.O. · 2019
- Descendant · 3 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 3 generations on · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- Descendant · 4 generations on · 7 of its ownK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K172819LightWalker Laser System FamilyFotona D.O.O. · 2017 · cites it directly20descendants
- K191554LightWalker Laser System FamilyFotona D.O.O. · 2019 · 2 generations on19descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 3 generations on11descendants
- K193661LightWalker Laser System FamilyFotona D.O.O. · 2020 · 3 generations on8descendants
- K202985LightWalker Laser System FamilyFotona D.O.O. · 2021 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030290 | Periolase ND:Yag Dental Laser System | Millennium Dental Technologies, Inc. | 2004 | — |
| 0 (this device) | K151763 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2016 | — |
| +1 | K172819 | LightWalker Laser System Family | Fotona D.O.O. | 2017 | — |
| +2 | K191554 | LightWalker Laser System Family | Fotona D.O.O. | 2019 | — |
| +3 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +3 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| +4 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K030290 | Periolase ND:Yag Dental Laser SystemSummary page 5…Device Class: Class II Product Code: GEX 2. Legally Marketed Predicate Device: PerioLase, Millennium Dental Technologies, K030290 3. Device Description: PerioLase Nd:YAG Pulsed Dental Laser System (same as K010771, K014272, and K030290) The laser… | 2004 |
What descends from it? (22)
See all 222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 PerioLase Nd:YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization 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…
Read the full statement (273 words)
The PerioLase Nd:YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization 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 and plastic surgery, neurosurgery, gynecology, urology, ophthalmology, and pulmonary general surgery. The following are the oropharyngeal indications for use for which the device will be marketed:
Oropharyngeal
• Abscess incision and drainage
• Aphthous ulcers treatment
• Biopsies excision and incision
• Crown lengthening
• Hemostatic assistance
• Fibroma removal
• Frenectomy
• Frenotomy
• Gingival incision and excision
• Gingivectomy
• Gingivoplasty
• Operculectomy
• Oral papillectomy
• Tissue retraction for impression
• Vestibuloplasty
• Selective ablation of enamel (first degree) caries
• Exposure of unerupted / partially erupted teeth
• Implant recovery
• Lesion (tumor) removal
• Leukoplakia
• Pulpotomy
• Pulpotomy as adjunct to root canal therapy
• Removal of filling material such as gutta-percha or resin as adjunct treatment during root canal retreatment
• Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility
• Laser-assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
• Periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151763: PerioLase Nd:YAG Pulsed Dental Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151763
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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