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Companies / Black & Black Surgical
Medical device company profile

Black & Black Surgical

Tucker, Georgia manufacturer and supplier of plastic-surgery instruments, electrosurgical accessories, and Vitruvian liposuction equipment.

Manufacturer / SupplierDermatology & AestheticsPlastic SurgeryCommercial stage
HeadquartersπŸ‡ΊπŸ‡ΈTucker, Georgia, United States
Founded2007
Commercial statusCommercially availableEstablished professional instrument catalog and powered equipment; direct U.S. sales and international distribution.
Employees11–50 [1]LinkedIn company-size range Β· Checked 2026-10-16
Estimated revenueNot confirmed
Official websitewww.blackandblacksurgical.com β†—

Company overview

Black & Black Surgical supplies instruments and equipment for plastic, cosmetic, facial plastic and reconstructive surgery. The company identifies 2007 as its operating start and is based in Tucker, Georgia. Its model combines surgeon-informed product development with a network of German and U.S. manufacturing suppliers.

Its portfolio spans reusable manual instruments and cannulas alongside powered Vitruvian equipment and electrosurgical accessories. Four FDA 510(k) decisions are mapped to marketed families, while representative manual-forceps and cannula listings identify premarket exemption. Neither route should be generalized to every catalog item.

In March 2025, Dorian Drake announced an agreement to expand sales and distribution in ten Latin American markets. The company serves surgical practices and facilities through direct ordering and international dealers. Current revenue, funding totals and independently measured customer or procedure volumes remain unconfirmed.

[1][2][19][20][21]

Leadership

4 people
Norman BlackCo-Founder; CEO identified in 2024 FDA filing [8]
Bill BlackCo-Founder [1]
Mike LaceyFounding Partner [1]
Tim BlackVice President [2]

Products & regulatory status How does MedTechIndex get this information?

Summary

Mixed portfolio: cleared Class II Vitruvian/electrosurgical devices and representative exempt GEN forceps / GEA cannulas. Exemption applies to qualifying specific devices, not the whole company, and is not FDA approval. [5][6][7][8][3][4][16][17][18][19][25]

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [27][28]

Regulatory snapshot How to read this snapshot

U.S. FDA
4
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Power-assisted liposuction system

Vitruvianβ„’ Liposaberβ„’ β†—

Reciprocating handpiece and control unit for power-assisted liposuction, with current catalog cannulas and accessories. [18][8]

FDA-cleared

Commercially marketed; confirm model, accessory compatibility and regional availability with the supplier.

Liposuction aspirator

Vitruvianβ„’ Ultimate Aspirator β†—

Powered vacuum system for aspiration during liposuction procedures. [24][6]

FDA-cleared

Commercially marketed; confirm model, accessory compatibility and regional availability with the supplier.

Tumescent infiltration pump

Vitruvianβ„’ Infiltration Pump β†—

Peristaltic pump for controlled delivery of tumescent fluid during body-contouring procedures. Current configuration details require current labeling review. [22][7]

FDA-cleared

Commercially marketed; confirm model, accessory compatibility and regional availability with the supplier.

Reusable manual surgical instruments

Manual plastic-surgery instruments β€” representative forceps β†—

Broad catalog includes scissors, forceps, retractors, rasps and procedure sets. The verified exempt example is a manual forceps SKU, not every item in the catalog. [3]

Exemption documented

Commercially marketed; confirm model, accessory compatibility and regional availability with the supplier.

Reusable liposuction cannulas

Liposuction cannulas β€” representative reusable SKU β†—

Company markets multiple cannula designs and interfaces. Exempt listing verified for representative GEA cannula DI 00840329837846; compatibility and processing are SKU-specific. [4]

Exemption documented

Commercially marketed; confirm model, accessory compatibility and regional availability with the supplier.

Commercial development

Commercial activity includes iterative instrument design and international distribution expansion. No verified investigational program or human comparative efficacy claim is asserted. [21][2]

Activity & Milestones

6 events
2025-03-20 Β· Distribution

Latin American export agreement announced

Dorian Drake reported a sales, marketing and distribution agreement for ten named markets. Publication date is March20; release dateline is March19. [2]

2024-09-13 Β· Regulatory

Vitruvian Liposaber cleared

FDA issued K240188 for the named device family. [8]

2017-06-22 Β· Regulatory

Vitruvian Infiltration Pump cleared

FDA issued K170629 for the named device family. [7]

2016-07-26 Β· Regulatory

Vitruvian Ultimate Aspirator cleared

FDA issued K161722 for the named device family. [6]

2008-01-18 Β· Regulatory

Electrosurgical accessories cleared

FDA issued K072124 for the named device family. [5]

2007 Β· Company

Company begins operations

Company narrative identifies a 2007 start with Norman and Bill Black and partner Mike Lacey. [1]

30 Cited Sources

Accessed 10/20/2026

[1] Black & Black Surgical β€” founding, founders and employee band β†—Black & Black Surgical / LinkedIn Β· company profile
[2] Dorian Drake export agreement β€” March 2025 β†—Dorian Drake International Β· partner announcement
[3] AccessGUDID β€” representative manual forceps, DI 00840329831912 β†—FDA / National Library of Medicine Β· device listing
[13] FDA K240188 β€” Vitruvian Liposaber β†—U.S. Food and Drug Administration Β· regulatory record
[14] FDA K170629 β€” VITRUVIAN INFILTRATION PUMP β†—U.S. Food and Drug Administration Β· regulatory record
[15] FDA K161722 β€” VITRUVIAN ULTIMATE ASPIRATOR β†—U.S. Food and Drug Administration Β· regulatory record
[16] FDA K943426 β€” ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE β†—U.S. Food and Drug Administration Β· regulatory record
[17] FDA K113795 β€” SUCTION LIPOLASTY ACCESSORIES β†—U.S. Food and Drug Administration Β· regulatory record
[18] Vitruvian Liposaber β€” current commercial system β†—Black & Black Surgical Β· company website
[19] Black & Black Surgical β€” current portfolio β†—Black & Black Surgical Β· company website
[20] Black & Black Surgical β€” Tucker office β†—Black & Black Surgical Β· company website
[22] Vitruvian Infiltration Pump β†—Black & Black Surgical Β· company website
[23] Electrosurgical instruments β€” marketed category β†—Black & Black Surgical Β· company website
[24] Vitruvian Ultimate Aspirator β†—Black & Black Surgical Β· company website
[25] FDA 510(k) database β€” research search β†—FDA / openFDA Β· regulatory record
[26] FDA PMA database β€” research search β†—FDA / openFDA Β· regulatory record
[29] FDA UDI database β€” research search β†—FDA / openFDA Β· regulatory record
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