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 Jun 5, 2013 as substantially equivalent to K102359 (Amd Lasers, LLC, 2011) and 1 other predicate after a 330-day review. Its family tree reaches back 18 generations to 1995. 4 later devices descend from it.
- Decided
- Jun 5, 2013
- Review
- 330 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 191 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 2 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 1 generation backK111689 StlaseDental Photonics, Inc. · 2012
- This deviceK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
- Descendant · cites it directly · 3 of its ownK162114 Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK200693 K2 MobileHulaser, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK261047 Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK201387 Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. · 2021
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- 3 generations backK081015 Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc. · 2008
- 2 generations backK094049 Stlase Diode LaserDental Photonics, Inc. · 2010
- 1 generation backK111689 StlaseDental Photonics, Inc. · 2012
- This deviceK122020 Photon Photon PlusZolar Technology & Mfg Co., Inc. · 2013
Most influential descendants
Showing 4 of 4 · See all- K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. · 2016 · cites it directly3descendants
- K200693K2 MobileHulaser, Inc. · 2020 · 2 generations on2descendants
- K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| −3 | K081015 | Ceralas D 980NM Diode Laser, Models D15 and D25 | Biolitec, Inc. | 2008 | — |
| −2 | K094049 | Stlase Diode Laser | Dental Photonics, Inc. | 2010 | — |
| −1 | K111689 | Stlase | Dental Photonics, Inc. | 2012 | — |
| 0 (this device) | K122020 | Photon Photon Plus | Zolar Technology & Mfg Co., Inc. | 2013 | — |
| +1 | K162114 | Photon, Photon Plus | Zolar Technology & Mfg Co., Inc. | 2016 | — |
| +2 | K200693 | K2 Mobile | Hulaser, Inc. | 2020 | — |
| +3 | K261047 | Dental Diode Laser Device (Laser-Pen) | Guilin Kevin Peter Technology Co., Ltd. | 2026 | — |
| +3 | 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 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 13 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 11 | 0 |
| 1999 | 8 | 0 |
| 2000 | 14 | 0 |
| 2001 | 13 | 0 |
| 2002 | 17 | 0 |
| 2003 | 14 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K102359 | Picasso/ Picasso Lite/ Picasso PerioSummary page 1…gulatory Class: Class 11 Product Code: GEX 3. Common or Usual Name: Dental Diode Laser 4. Predicate Device Information: ~ Picasso/Picasso Lite Dental Diode Lasers, K102359 stLase Dental Laser, K111689 5. Device Description: The Photon/Photon Plus is intended for use by dentists in oral soft tissue… | 2011 |
| * | K111689 | StlaseSummary page 1…uct Code: GEX 3. Common or Usual Name: Dental Diode Laser 4. Predicate Device Information: ~ Picasso/Picasso Lite Dental Diode Lasers, K102359 stLase Dental Laser, K111689 5. Device Description: The Photon/Photon Plus is intended for use by dentists in oral soft tissue and tooth whitening procedure… | 2012 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162114 | Photon, Photon Plus | 2016 | 3 |
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 18 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 7 of the 191 ancestors have a recall of any class.
- Of its descendants, K162114 (Zolar Technology & Mfg Co., Inc., 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K102359.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Photon is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. Exposure of Unerupted teeth Fibroma removal Frenectomy Gingival Troughing for crown impressions Gingivectomy Gingivoplasty Hemostasis and…
Read the full statement (331 words)
The Photon is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows:
SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation.
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.
LASER PERIODONTAL PROCEDURES:
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
The Photon Plus is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows:
SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation.
Exposure of Unerupted teeth
Excision of lesion or removal of Granulation tissue
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
LASER PERIODONTAL PROCEDURES:
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)
Debridement of diseased epithelial lining
TOOTH WHITENING INDICATIONS
Laser assisted whitening/bleaching of teeth
Light activation for bleaching materials for teeth whitening.
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/K122020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122020: 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/K122020
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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