510(k) · Cleared
ClearedLares Research Sunlase 800P Laser System (to BE Sold as Pocketpro or Pocketpro S4)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lares Research, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 21, 2001 after a 182-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Dec 21, 2001
- Review
- 182 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK011960 Lares Research Sunlase 800P Laser System (to BE Sold as Pocketpro or…Lares Research, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK182930 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011960 | Lares Research Sunlase 800P Laser System (to BE Sold as Pocketpro or Pocketpro… | Lares Research, Inc. | 2001 | — |
| +1 | K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (8)
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 |
|---|---|---|---|
| * | — | American Dental Technologies - PulseMaster™ Named without a submission number | |
| * | — | American Dental Technologies - DioLase ST™ Named without a submission number | |
| * | — | BioLase Technology, Inc. - TwiLite™ Named without a submission number | |
| * | — | CeramOptec - Ceralas® D15 Named without a submission number | |
| * | — | Dentek Laser Systems - LD-15™ Named without a submission number | |
| * | — | OpusDent, Ltd. - Opus 10™ Named without a submission number | |
| * | — | Premier Laser Systems - Aurora™ Named without a submission number | |
| * | — | Xintec Corporation - Dentica™ Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | 2019 | 0 |
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?
- Of its descendants, K182930 (Millennium Dental Technologies, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The device is indicated 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, dermatology and plastic surgery. The following are the…
Read the full statement (282 words)
The SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The device is indicated 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, dermatology and plastic surgery. The following are the oropharangeal indications for use for which the device will be marketed:
- Excisional and incisional biopsies
- Excision and vaporization of herpes simplex | and ||
- Exposure of unerupted teeth
« Fibroma removal
« Frenectomy and Frenotomy
« Gingival troughing for crown impressions
« Gingivectomy
« Gingivoplasty
- Gingival incision and excision
« Hemostasis
+ Implant recovery
« Incision and drainage of abscess
. Laser Assisted Uvulopaletoplasty (LAUP)
This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring.
« Leukoplakia
« Operculectomy
« Oral Papillectomies
« Pulpotomy and 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 adjunct treatment during root canal therapy
- 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 loss, and tooth mobility)
« Tissue retraction for impression
« Treatment of Apthous ulcers
« Vestibuloplasty
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/K011960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011960: Lares Research Sunlase 800P Laser System (to BE Sold as Pocketpro or Pocketpro S4).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011960
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026