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 Jul 12, 2019 as substantially equivalent to K151763 (Millennium Dental Technologies, Inc., 2016) and 4 other predicates after a 263-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Jul 12, 2019
- Review
- 263 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K943450 (1995). 189 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 2 generations backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- 1 generation backK121508 Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012
- This deviceK182930 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 7 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 6 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 5 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 4 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 3 generations backK090126 Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona…Fotona D.D. · 2009
- 2 generations backK101306 SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP…Fotona D.D. · 2011
- 1 generation backK121508 Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D. · 2012
- This deviceK182930 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −7 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −6 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −5 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −4 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| −3 | K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP… | Fotona D.D. | 2009 | — |
| −2 | K101306 | SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models… | Fotona D.D. | 2011 | — |
| −1 | K121508 | Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N | Fotona D.D. | 2012 | — |
| 0 (this device) | K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 12 | 0 |
| 1995 | 10 | 0 |
| 1996 | 18 | 0 |
| 1997 | 19 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 14 | 0 |
| 2001 | 15 | 0 |
| 2002 | 18 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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? (5)
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 |
|---|---|---|---|
| * | K151763 | PerioLase Nd:YAG Pulsed Dental Laser SystemSummary page 6…Device Class: Class II Product Code: GEX 2. Legally Marketed Predicate Devices: PerioLase, Millennium Dental Technologies, K151763 PinPointe FootLaser, PinPointe USA, K093547 Lightwalker Nd:YAG, Fotona, K121508 SunLase 800 P (PocketPro), Lares Researc… | 2016 |
| * | K093547 | Pinpointe FootlaserSummary page 6…Product Code: GEX 2. Legally Marketed Predicate Devices: PerioLase, Millennium Dental Technologies, K151763 PinPointe FootLaser, PinPointe USA, K093547 Lightwalker Nd:YAG, Fotona, K121508 SunLase 800 P (PocketPro), Lares Research, K011960 Dentica, Xintec, K971065 3. Devi… | 2010 |
| * | K121508 | Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NSummary page 6…. Legally Marketed Predicate Devices: PerioLase, Millennium Dental Technologies, K151763 PinPointe FootLaser, PinPointe USA, K093547 Lightwalker Nd:YAG, Fotona, K121508 SunLase 800 P (PocketPro), Lares Research, K011960 Dentica, Xintec, K971065 3. Device Description: PerioLase Nd:YAG Pul… | 2012 |
| * | K011960 | Lares Research Sunlase 800P Laser System (to BE Sold as Pocketpro or Pocketpro S4)Summary page 6…llennium Dental Technologies, K151763 PinPointe FootLaser, PinPointe USA, K093547 Lightwalker Nd:YAG, Fotona, K121508 SunLase 800 P (PocketPro), Lares Research, K011960 Dentica, Xintec, K971065 3. Device Description: PerioLase Nd:YAG Pulsed Dental Laser System (same as K010771, K014272,… | 2001 |
| * | K971065 | Dentica Pulsed ND: Yag Laser Systems and AccessoriesSummary page 6…, K151763 PinPointe FootLaser, PinPointe USA, K093547 Lightwalker Nd:YAG, Fotona, K121508 SunLase 800 P (PocketPro), Lares Research, K011960 Dentica, Xintec, K971065 3. Device Description: PerioLase Nd:YAG Pulsed Dental Laser System (same as K010771, K014272, K030290, and K151763) T… | 1997 |
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 24 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 189 ancestors have a recall of any class.
- 1 other device also cites its predicate K151763.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and…
Read the full statement (652 words)
The PerioLase Nd:YAG Pulsed Dental Laser System is intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and urology.
Orophayrngeal / Dental Surgery
• Abscess incision and drainage
• Aphthous ulcers treatment
• Biopsies, incisional and excisional
• Excision and ablation of benign lesions and conditions
• Excision and vaporization of herpes simplex I and II
• Exposure of unerupted / partially erupted teeth
• Facilitation of subgingival calculus removal
• Fibroma removal
• Frenectomy
• Frenotomy
• Gingival incision and excision
• Gingival troughing for crown impressions
• Gingivectomy
• Gingivoplasty
• Hemostasis
• Hemostatic assistance
• Implant recovery
• Incision of infection when used with antibiotic therapy
• Laser-assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
• Laser-assisted uvulopalatoplasty (LAUP)
• Lesion (tumor) removal
• Leukoplakia
• Modification of the dentin surface, including increasing the mineral and decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces
• Operculectomy
• Oral papillectomy
• 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
• Pulpotomy
• Pulpotomy as an adjunct to root canal therapy
• Reduction of denture hyperplasia
• Reduction of gingival hypertrophy
• Removal of filling material such as gutta percha or resin as an adjunct treatment during root canal retreatment
• Removal of post-surgical granulations
• Selective ablation of enamel (first degree) caries removal
• Soft tissue crown lengthening
• Sulcular debridement or soft tissue curettage (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 or loss, and tooth mobility
• Tissue retraction for impression
• Vestibuloplasty
General Surgery
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands
• Appendectomy
• Cholecystecomy
• Debridement of decubitus ulcers
• Hemorrhoidectomy
• Hepatectomy
• Herniorrhaphy
• Lymphadenectomy
• Mastectomy
• Pancreatectomy
• Parathyroidectomy
• Partial nephrectomy
• Pelvic adhesiolysis
• Pilonidal cystectomy
• Removal of fibromas
• Removal of lesions
• Removal of polyps
• Removal of tumors
• Resection of lipoma
• Splenectomy
• Thyroidectomy
• Tonsillectomy
• Tumor biopsy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• Adenoidectomy
• Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues
• Tonsillectomy
Dermatology and Plastic Surgery
Dematology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• Debridement of decubitus ulcer
• Hemangiomas
• Lesions of skin and subcutaneous tissue
• Periungual and subungual warts
• Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins
• Plantar warts
• Port wine lesions
• Removal of tattoos
• Spider veins
• Telangiectasia
• Treatment of keloids
• Treatment of mild to moderate inflammatory acne vulgaris
• Treatment of wrinkles
• Venous lakes
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
• Matrixectomy
• Periungual and subungual warts
• Plantar warts
• Radical nail excision
• Neuromas
The PerioLase® MVP-7™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182930 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182930: 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/K182930
Report an extraction error
Are you the manufacturer?
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