510(k) · Cleared
ClearedHandPICO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vydence Medical Industria E Comercio Ltda · GEX Powered Laser Surgical Instrument
Cleared on May 5, 2022 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 5, 2022
- Review
- 120 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK220041 HandPICOVydence Medical Industria E Comercio Ltda · 2022
- Descendant · cites it directly · 0 of its ownK252753 Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026
Most influential descendants
Showing 1 of 1 · See all- K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K220041 | HandPICO | Vydence Medical Industria E Comercio Ltda | 2022 | — |
| +1 | K252753 | Vydence Family of Lasers | Vydence Medical Industria E Commercio Ltda | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K252753 | Vydence Family of Lasers | 2026 | 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, K252753 (Vydence Medical Industria E Commercio Ltda, 2026) 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. 2022, 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?
IPL 390nm-510nm Filter * The treatment of inflammatory acne (acne vulgaris); * The treatment of leukoderma, including vitiligo (acquired leukoderma). IPL 400nm-1200nm Filter * The treatment of moderate inflammatory acne vulgaris; * The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles); » the treatment of benign cutaneous lesions including warts, scars and striae; * The treatment of…
Read the full statement (1,943 words)
IPL 390nm-510nm Filter
* The treatment of inflammatory acne (acne vulgaris);
* The treatment of leukoderma, including vitiligo (acquired leukoderma).
IPL 400nm-1200nm Filter
* The treatment of moderate inflammatory acne vulgaris;
* The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides
(freckles);
» the treatment of benign cutaneous lesions including warts, scars and striae;
* The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, Poikiloderma of Civatte, leg veins and
venous malformations.
* Use on all skin types (Fitzpatrick I-VI).
IPL 515-1200nm Filter
* The treatment of moderate inflammatory acne (acne vulgaris).
* The treatment of tattoos and benign pigmented epidermal and benign cutaneous lesions including warts, scars, striae,
dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and café-aulait macules.
* The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and
venous malformations.
* The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair
growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months
after the completion of a treatment regime.
* Use on Fitzpatrick skin types I-V.
IPL 540nm-1200nm Filter
* benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles),
* lentigines, nevi, and cafe-au-lait macules;
» the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and
venous malformations.
* The treatment of benign cutaneous lesions including warts, scars and striae.
* The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair
growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 and 12
months after the completion of a treatment regime.
* Use on all skin types (Fitzpatrick 1-VI).
IPL 580nm-1200nm Filter
* The treatment of moderate inflammatory acne vulgaris.
* The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides
(freckles).
* The treatment of face and body benign vascular and benign pigmented lesions.
* The treatment of benign cutaneous lesions, including scars and striae.
* The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg
telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous
malformations.
* The removal of unwanted hair to effect stable long-term or permanent hair reduction. . Permanent reduction in hair
growth is defined as the long-term , stable reduction in the number of hairs regrowing when measured at 6,9 an 12 months
after the completion of a treatment regime.
* Use on all skin types (Fitzpatrick 1-VI).
IPL 640nm-1200nm Filter
» the treatment of tattoos;
* The treatment of mild to moderate inflammatory and pustular inflammatory acne vulgaris;
* The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides
(freckles), lentigines, nevi, melasma, and cafe-au-lait;
» the treatment of benign cutaneous lesions including warts, scars and striae;
» the treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg
telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and
venous malformations;
» removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the
long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a
treament regimen).
* Use on all skin types (Fitzpatrick I-V1), including tanned skin.
IPL 695n1m-1200nm Filter
» removal of unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the
long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a
treatment regimen).
* Use on all skin types (Fitzpatrick I-VI), including tanned skin
Intense IR Handpiece
» intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue
temperature. It’s also indicated for the treatment in the temporary relief of minor muscle pain and joint pain and stiffness,
the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied,
and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
1064nm Long Pulse Handpiece
» removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is
indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term,
stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment
regime;
* Treatment of pseudofolliculitis barbae (PFB)
* Benign vascular lesions such as, but not limited to treatment of: Port wine stains; Hemangiomas; Warts; Superficial and
deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider
veins; Poikiloderma of Civatte; Angiomas
* Benign pigmented lesions such as, but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Caf¢-au-lait
macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; verrucae, skin tags, keratoses, the removal of black,
blue, or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos), plaques
* Benign cutaneous lesions, such as, but not limited to warts, scars, striae and psoriasis
» Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive
treatment, and for patients with lesions that have not responded to other laser treatments.
» The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral wrinkles
* Laser skin resurfacing procedures for the treatment of: Acne scars, wrinkles
* Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
1064nm Long Pulse Handpiece - Short Pulse Operation
» intended for the coagulation and hemostasis of benign vascular lesions such as but not limited to, rosacea/ diffuse
redness, poikiloderma of civatte, scar reduction (including hypertropic and keloidscars), and warts.
» is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
» For use on all skin types (Fitzpatrick I-VI), including tanned skin.
1064nm Long Pulse Handpiece - Onychomycosis
* podiatry (i.e. ablation, vaporization, incision, excision, and coagulation of soft tissue) including matrixectomy, radical
nail excision, periungual and subungual warts, plantar warts, neuromas,
* temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and
Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
Acroma Handpiece
The 1064 nm wavelength is indicated for:
» treatment of benign vascular lesions such as (but not limited to): port wine stains; hemangiomas; warts; superficial and
deep telangiectasias (venulectasias); reticular veins (0.1-4.0 mm diameter) of the leg; rosacea; venous lakes; leg veins;
spider veins; Poikiloderma of Civatte; angiomas;
* benign cutaneous lesions, such as, but not limited to: warts; scars; striae; psoriasis;
* benign pigmented lesions such as, but not limited to: lentigos (age spots); solar lentigos (sun spots); cafe-au-lait
macules; seborrheic keratoses; nevi and Nevus of Ota; chloasma; verrucae; skin tags; keratoses; the removal of black, blue
or green tattoos (significant reduction in the intensity of black and/or blue/black tattoos); plaques;
» pigmented benign lesions to reduce lesions’ size for patients with lesions that would potentially benefit from aggressive
treatment, and for patients with lesions that have not responded to other laser treatments.
» the non-ablative treatment of facial wrinkles, including but not limited to: periocular wrinkles; perioral wrinkles;
» laser skin resurfacing procedures for the treatment of acne scars; wrinkles,
» reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
» indicated for use on all skin types (Fitzpatrick 1-VI), including tanned skin.
The 532 nm wavelength is indicated for:
* incision, excision, ablation, vaporization of soft tissue;
* tattoo removal: light blue, yellow, red; green;
* benign vascular lesions: Hemangiomas (port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); angiomas
(cherry, spider); telangiectasias; spider nevi;
* benign pigmented lesions: cafe-au-lait macules; lentigines (senile and solar); freckles (ephelides); chloasma; nevi; nevus
spillus; Nevus of Ota; Becker's Nevi;
» other benign pigmented cutaneous lesions: verrucae; skin tags; keratoses; plaques
1540 GoSmooth Handpiece
* The 1540 Fractional Non-ablative Laser Handpiece is intended for use in the coagulation of soft tissue, skin resurfacing
procedures as well as treatment of melasma, striae, acne scars and surgical scars.
2940 DualMode Handpiece
* DERMATOLOGY AND PLASTIC SURGERY
Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins;
Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars); Debulking
benign tumors; Debulking cysts; Superficial skin lesions; Diagnostic biopsies; Decubitus ulcers;
* PODIATRY
Treatment of: Warts, plantar verrucae, large mosaic verrucae. Matrixectomy.
2940 DualMode — fractional — skin resurfacing
1340 ProDeep Handpiece
» fractional laser handpiece is intended for use in skin resurfacing
» collimated laser handpiece is intended for the treatment of fine lines and wrinkles; treatment of atrophic acne scars;
treatment of mild to moderate inflammatory acne vulgaris
755nm Fiber Delivered Handpiece (Zye and One)
755nm
* Intended for the temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin.
Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the
end of a treatment regime; epidermal lesions (benign pigmented lesions) such as solar melanosis, hyperpigmentation,
melasma, and ephelides, wrinkles, treatment of benign cutaneous lesions with vascular components including port wine
stains, hemangiomas, facial and bodily telangiectasia, erythematous rosacea, angiomas and spider angiomas, poikiloderma
of Civatte and superficial venous malformations.
1064nm Fiber Delivered Handpiece (Zye and One)
In long pulse mode, the ZYE YAG® applicator is designated for coagulation and hemostasis of vascular lesions and
epidermal tissue, including the treatment of telangiectasia, superficial varicosities, angiomas and spider angiomas,
hemangiomas, rosacea, and nevi. It is also designated for non-ablative treatment of facial wrinkles and for removal of
unwanted hair, for stable long term or permanent hair reduction (permanent hair reduction is defined as the long-term,
stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment
regimen); for the treatment of pseudofolliculitis barbae (PFB). Use on all skin types (Fitzpatrick I-V1), including tanned
skin.
* In the DYNAMICS® mode, for temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes
Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.).
* In the INTENSE® mode is intended for non-invasive Laser assisted lipolysis;
HandPICO Handpiece
532nm (pico-second):
» Removal of tattoos for Fitzpatrick skin types I-11I with the following tattoo colors: red, yellow and orange;
» Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
1064nm (pico-second):
» Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green,
blue and purple.
* Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm (nano-second):
» Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
» Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-11I
1064nm (nano-second):
* Treatment of benign pigmented lesions on Fitzpatrick skin types [-VI
» Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220041: HandPICO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220041
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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