510(k) · Cleared
ClearedSuperbium
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bios S.R.L. · GEX Powered Laser Surgical Instrument
Cleared on Apr 12, 2016 as substantially equivalent to K072344 (Bios S.R.L., 2007) and 5 other predicates after a 158-day review. Its family tree reaches back 17 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 12, 2016
- Review
- 158 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 17 generations to K910422 (1992). 359 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations between
- 3 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 2 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 1 generation backK103664 Primus Aesthetic PlatformPalomar Medical Technologies, Inc. · 2011
- This deviceK153229 SuperbiumBios S.R.L. · 2016
- Descendant · cites it directly · 0 of its ownK252561 BTL-754FFBTL Industries, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK163196 ACTION II Laser SystemLutronic Corporation · 2017
Show all 17 generations
- Root · 17 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 16 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 15 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 14 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 13 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 12 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 11 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 10 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 9 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 8 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 7 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 6 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 5 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 4 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 3 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 2 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 1 generation backK103664 Primus Aesthetic PlatformPalomar Medical Technologies, Inc. · 2011
- This deviceK153229 SuperbiumBios S.R.L. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −16 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −15 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −14 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −13 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −12 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −11 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −10 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −9 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −8 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −7 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −6 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −5 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −4 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −3 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −2 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −1 | K103664 | Primus Aesthetic Platform | Palomar Medical Technologies, Inc. | 2011 | — |
| 0 (this device) | K153229 | Superbium | Bios S.R.L. | 2016 | — |
| +1 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
| +1 | K163196 | ACTION II Laser System | Lutronic Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 3 | 0 |
| 1990 | 3 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 16 | 0 |
| 1995 | 17 | 0 |
| 1996 | 23 | 0 |
| 1997 | 24 | 0 |
| 1998 | 21 | 0 |
| 1999 | 13 | 0 |
| 2000 | 25 | 0 |
| 2001 | 28 | 0 |
| 2002 | 38 | 0 |
| 2003 | 31 | 0 |
| 2004 | 20 | 0 |
| 2005 | 17 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (6)
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 |
|---|---|---|---|
| * | K072344 | Apl Medical SystemSummary page 7…GEX, ONG, ONF III. PREDICATE DEVICE 510(k) Number Pro Code Trade Name Applicant K072344 GEX 21 CFR 878.4810 APL MEDICAL SYSTEM BIOS FTC 21 CFR 87… | 2007 |
| * | K103664 | Primus Aesthetic PlatformSummary page 7…Applicant K072344 GEX 21 CFR 878.4810 APL MEDICAL SYSTEM BIOS FTC 21 CFR 878.4630 K103664 GEX, ONG ICON AESTHETIC SYSTEM Palomar 21 CFR §… | 2011 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 7…1 CFR 878.4630 K103664 GEX, ONG ICON AESTHETIC SYSTEM Palomar 21 CFR § 878.4810 K072564 GEX, FTC, HHR, LNK HARMONY XL ALMA 21 CFR 878.4… | 2008 |
| * | K150140 | MCL 31 DermablateSummary page 7…GEX, FTC, HHR, LNK HARMONY XL ALMA 21 CFR 878.4810 MULTI APPLICATION PLATFORM K150140 GEX 21 CFR 878.4810 DERMABLATE ASCLEPION K111303 GEX 21 CFR… | 2015 |
| * | K111303 | Dermatological Treatment Device FamilySummary page 7…21 CFR 878.4810 MULTI APPLICATION PLATFORM K150140 GEX 21 CFR 878.4810 DERMABLATE ASCLEPION K111303 GEX 21 CFR 878.4810 OMNIMAX SHARPLIGHT… | 2011 |
| * | K090195 | Palomar LUX1540 HandpieceSummary page 7…878.4810 OMNIMAX SHARPLIGHT TECHNOLOGIES K090195 GEX 21 CFR 878.4810 LUX 1540 PALOMAR IV. DEVICE DESCRIPTION The p… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 13 of the 359 ancestors have a recall of any class.
- Of its descendants, K252561 (BTL Industries, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K072344.
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?
The Nd:Yag 1064 Laser Handpiece (Long Pulsed) is intended for: -treatment of benign vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; -treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; -tattoos (significant…
Read the full statement (1,400 words)
The Nd:Yag 1064 Laser Handpiece (Long Pulsed) is intended for:
-treatment of benign vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea,
venus lake, facial and leg veins;
-treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots),
pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;
-tattoos (significant reduction in the intensity of black and/or blue-black tattoos);
verrucae, skin tags, seborrheic keratosis;
- reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
- coagulation and hemostasis of soft tissue;
-the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent
reduction in hair regrowth 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.
The Nd:Yag 1064 Laser Handpiece (Short Pulsed) is intended for:
Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles
The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:
- 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 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 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.
-Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:
-Incision, excision, ablation, vaporization of soft tissue.
- Tattoo removal: Light blue; Yellow; Red; Green
-Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas
(cherry, spider); Telangiectasia; 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
The 2940 nm Er:YAG Laser Module handpiece is indicated for:
Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT,
Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
Laser skin resurfacing procedures for the treatment of:
• Acne scars
• Wrinkles
The 2940 nm Er:Yag Fractional tips are indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus,
mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to:
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).
The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing
procedures as well as treatment of melasma, striae, acne scars and surgical scars.
IPL 400-1200 run handpiece is indicated for:
• 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).
IPL500-1200 nm handpiece is indicated for:
• The treatment of moderate inflammatory acne (acne vulgaris).
• The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae,
dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, 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 removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair
regrowth 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 Fitzpatrick skin types I-V.
IPL 550-1200 nm handpiece is indicated for:
• The treatment of moderate inflammatory acne Vulgans.
• The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides
(freckles).
• The treatment of face and body vascular and pigmented lesions.
• The treatment of 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
regrowth 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 I-VI).
IPL 580-1200 run handpiece is indicated for:
• 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 vascular and pigmented lesions.
• The treatment of 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
regrowth 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 I-VI).
IPL 620-1200 nm handpiece is indicated for:
• The treatment of tattoos.
• The treatment of moderate 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 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.
: The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair
regrowth 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 I-VI), including tanned skin.
IPL 755-1200 nm handpiece is indicated for:
• The treatment of tattoos.
• The treatment of moderate inflammatory acne vulgaris.
• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides
(freckles).
• The treatment of 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.
• The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis.
• The treatment of pseudofolliculitis barbae (PFB).
• The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair
regrowth 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 I-VI), including tanned skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153229: Superbium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153229
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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