510(k) · Cleared
ClearedPinpointe Footlaser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pinpointe USA, Inc. · PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Cleared on Oct 15, 2010 as substantially equivalent to K083616 (Patholase, Inc., 2009) and 1 other predicate after a 332-day review. Its family tree reaches back 7 generations to 1994. 115 later devices descend from it.
- Decided
- Oct 15, 2010
- Review
- 332 days
- Class
- Class II
- Product code
- PDZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K936109 (1994). 33 ancestors in all, the oldest K853620 (1986). 115 later devices descend from it, 12 citing it directly.
- Root · 7 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 6 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 5 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 4 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 3 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 2 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 1 generation backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- This deviceK093547 Pinpointe FootlaserPinpointe USA, Inc. · 2010
- Descendant · cites it directly · 65 of its ownK113702 Fotona XP ND: Yag Laser SystemFotona D.D. · 2012
- Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · cites it directly · 35 of its ownK110370 Q-ClearLight Age, Inc. · 2011
- Descendant · cites it directly · 34 of its ownK113810 Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012
- Descendant · 2 generations on · 33 of its ownK133837 Viora V-TotalViora, Ltd. · 2014
Showing 5 of 115 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 115 · See all- K113702Fotona XP ND: Yag Laser SystemFotona D.D. · 2012 · cites it directly65descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 2 generations on62descendants
- K110370Q-ClearLight Age, Inc. · 2011 · cites it directly35descendants
- K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc. · 2012 · cites it directly34descendants
- K133837Viora V-TotalViora, Ltd. · 2014 · 2 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −6 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −4 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −3 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −2 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −1 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| 0 (this device) | K093547 | Pinpointe Footlaser | Pinpointe USA, Inc. | 2010 | — |
| +1 | K113702 | Fotona XP ND: Yag Laser System | Fotona D.D. | 2012 | — |
| +2 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +1 | K110370 | Q-Clear | Light Age, Inc. | 2011 | — |
| +1 | K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | Alma Lasers, Inc. | 2012 | — |
| +2 | K133837 | Viora V-Total | Viora, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 9 | 0 |
| 2024 | 13 | 0 |
| 2025 | 17 | 0 |
| 2026 | 12 | 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 PDZ? 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 PDZ device
- #1 K253960 Medicell Mycosis Laser (MCML24004)score 11.3 · 2 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 |
|---|---|---|---|
| * | K083616 | Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersSummary page 1…struments (and Accessories) (21 CFR Part 878.4810, Product Code GEX) IIL. Predicate Devices , e PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers (K083616) ¢ Incisive Family of InPulse Nd:YAG Lasers (K083215). IV. Product Description The PinPointe™ FootLaser™ is comprised of the f… | 2009 |
| * | K083215 | Incisive Family of Inpulse ND:Yag LasersSummary page 1…oduct Code GEX) IIL. Predicate Devices , e PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers (K083616) ¢ Incisive Family of InPulse Nd:YAG Lasers (K083215). IV. Product Description The PinPointe™ FootLaser™ is comprised of the following main components: o Main console containing t… | 2009 |
What descends from it? (115)
See all 11512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113702 | Fotona XP ND: Yag Laser System | 2012 | 65 |
| K110370 | Q-Clear | 2011 | 35 |
| K113810 | Modified Alma Lasers Harmony 1064NM (ND:Yag) Modules | 2012 | 34 |
| K120235 | Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo… | 2012 | 33 |
| K120938 | The PL-1064 Laser System | 2012 | 14 |
| K110375 | Blueshine's Gold Series | 2012 | 4 |
| K121508 | Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N | 2012 | 1 |
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | 2019 | 0 |
| K131805 | Inpulse Laser | 2013 | 0 |
| K130413 | Pinpointe Footlaser | 2013 | 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?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 33 ancestors has a recall of any class.
- Of its descendants, K113702 (Fotona D.D., 2012) has gone furthest, with 65 descendants of its own.
- 1 other device also cites its predicate K083616.
How does its category compare?
All PDZ devicesPDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · PDZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PDZ
196in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PDZ
No recall names PDZ since 2007.
Adverse event reports per year · PDZ
1in 2019
MAUDE reports naming product code PDZ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 205 | 0 | 0 |
| 2012 | 6 | 196 | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery…
Read the full statement (406 words)
The PinPointe™ FootLaser™ and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including intraoral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissuc) including:
Matrixectomy
Periungual and subungual warts
Plantar warts
Radical nail excision
Neuromas
The PinPointe™ FootLaser™ 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.).
Dermatology and Plastic Surgery
Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
Lesions of skin and subcutaneous tissue
Telangiectasia
Port wine lesions
Spider veins
Hemangiomas
Plantar warts
Periungual and subungual warts
Removal of tattoos
Debridement of decubitus ulcer
Treatment of keloids
Oropharangeal / Dental Surgery
Indicated for:
Abscess incision and drainage
Aphthous ulcers treatment
Biopsies, excisional and incisional
Crown lengthening
Exposure of unerupted / partially erupted teeth
Fibroma removal
Frenectomy
Frenotomy
Gingival incision and excision
Gingivectomy
Gingivoplasty
Oropharangeal / Deutal Surgery - Continued
Indicated for:
Hemostasis
Implant recovery
Lesion (tumor) removal
Leukoplakia
Operculectomy
Oral papillectomy
Pulpotomy
Pulpotomy as adjunct to root canal therapy
Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
Selective ablation of enamel (first degree) caries removal
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 loss, and tooth mobility
Tissue retraction for impressions
Vestibuloplasty
General Surgery
Indicated for:
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Cholecystectomy
- Lymphadenectomy
- Mastectomy
- Partial nephrectomy
- Hepatectomy
General Surgery - Continued
Indicated for:
- Pilonidal cystectomy
- Pancreatectomy
- Resection of lipoma
- Splenectomy
- Pelvic adhesiolysis
- Hemorrhoidectomy
- Removal of lesions
- Thyroidectomy
- Removal of polyps
- Parathyroidectomy
- Removal of tumors
- Hemiorrhaphy
- Tumor biopsy
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissuc) including:
- Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
- Tonsillectomy
- Adenoidectomy
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/K093547 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093547: Pinpointe Footlaser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093547
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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