510(k) · Cleared
ClearedPhoton, Photon Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zolar Technology & Mfg Co., Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 12, 2016 as substantially equivalent to K121286 (Biolase Technology, Inc., 2012) and 2 other predicates after a 136-day review. Its family tree reaches back 19 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 12, 2016
- Review
- 136 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K943450 (1995). 264 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 2 generations backK111689 StlaseDental Photonics, Inc. · 2012
- 1 generation backK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
- This deviceK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- Descendant · cites it directly · 2 of its ownK200693 K2 MobileHulaser, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK261047 Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK201387 Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. · 2021
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 4 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 3 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 2 generations backK111689 StlaseDental Photonics, Inc. · 2012
- 1 generation backK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
- This deviceK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −4 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| −3 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| −2 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
| −1 | K122020 | Photon Photon Plus | Zolar Technology & Mfg Co., Inc. | 2013 | — |
| 0 (this device) | K162114 | Photon, Photon Plus | Zolar Technology & Mfg Co., Inc. | 2016 | — |
| +1 | K200693 | K2 Mobile | Hulaser, Inc. | 2020 | — |
| +2 | K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | 2026 | — |
| +2 | K201387 | Ultrafast, Ultrafast Plus, Ultrafast Lite | Dentlight, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 15 | 0 |
| 1996 | 18 | 0 |
| 1997 | 24 | 0 |
| 1998 | 16 | 0 |
| 1999 | 12 | 0 |
| 2000 | 18 | 0 |
| 2001 | 19 | 0 |
| 2002 | 24 | 0 |
| 2003 | 19 | 0 |
| 2004 | 14 | 0 |
| 2005 | 7 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K121286 | EPIC 10Summary page 9…SE per K122020, as per K122020 as per K123443 K121286 K123443, K121286 Page 5 of 7 Subject… | 2012 |
| * | K123443 | Precise SHP Diode LaserSummary page 9…Indications as per FOR USE per K122020, as per K122020 as per K123443 K121286 K123443,… | 2013 |
| * | K122020 | Photon Photon PlusSummary page 7…minutes safely and effectively. 9. Substantial Equivalence: The purpose of this submission is to consolidate the current Photon/Photon Plus Laser Systems (K122020) with a new Pain Indication. The Subject Device Photon Dental Diode Laser is of a comparable type and substantially eq… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200693 | K2 Mobile | 2020 | 2 |
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 21 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 11 of the 264 ancestors have a recall of any class.
- Of its descendants, K200693 (Hulaser, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K121286.
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?
1. DENTAL SOFT TISSUE INDICATIONS The indications are identical to the previously cleared predicate systems. Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications: * Exposure of Unerupted teeth + Fibroma removal * Frenectomy « Gingival Troughing for crown impressions * Gingivectomy * Gingivoplasty »…
Read the full statement (244 words)
1. DENTAL SOFT TISSUE INDICATIONS
The indications are identical to the previously cleared predicate systems.
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival
and epithelial lining of free gingival and the following specific indications:
* Exposure of Unerupted teeth
+ Fibroma removal
* Frenectomy
« Gingival Troughing for crown impressions
* Gingivectomy
* Gingivoplasty
» Hemostasis and coagulation
« Gingival incision and excision hemostasis
Implant recovery
» Incision and drainage of abscess
* Leukoplakia
*» Operculectomy
* Oral papillectomies
* Pulpotomy as an adjunct to root canal therapy
* Reduction of gingival hypertrophy
« Soft tissue crown lengthening
« Gingival bleeding index
» Excisional and incisional biopsies
» Treatment of aphthous ulcer canker sores and herpetic.
* Vestibuloplasty
2. LASER PERIODONTAL INDICATIONS:
« Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices
including: probe depth, attachment loss and tooth mobility)
« Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional
epithelium.
3. TOOTH WHITENING INDICATIONS
» Laser Assisted whitening/bleaching of teeth.
» Light activation for bleaching materials for teeth whitening.
4. PAIN INDICATIONS:
» Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and
stiffness minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary
increase in local blood circulation; the temporary relaxation of muscle.
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/K162114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162114: Photon, Photon Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162114
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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